Career Opportunities

Corporate Summary

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

Location: Boulder, Colorado, United States

About our Company:  

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.


About the Role

The Clinical Laboratory Scientist II will be responsible for performing a variety of laboratory procedures involved in end-to-end processing of biological samples to enable successful downstream next-generation sequencing (NGS). Processing will include accessioning and both manual and automated extraction, library preparation, hybrid capture, sequencing and QC steps. Under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, you will work collaboratively within the clinical laboratory leveraging your technical knowledge, skills and abilities to ensure efficient and quality results are provided to our clients and patients while also informing/participating in process improvements. This position will report to the Director of Clinical Laboratory Operations.


Responsibilities 

Technical

  • Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.

  • Provide technical guidance and oversight to non-licensed personnel for pre-analytical, analytical and post-analytical activities.

  • Interpret data and results of all analyses according to set procedures and guidelines.

  • Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.

  • Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to clinical leadership as needed.

  • Assist with research, translational research, regulated products through the execution of partnership studies and internal/external validation studies.

  • Participate as a contributing member of the clinical laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.

  • Proposes assay and process improvements and conducts improvement activities under guidance.

  • Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.

  • Participate in new or revised assay launches giving input on launch logistics as appropriate.

  • Participate in work planning initiatives and scheduling.


Quality, Training & Equipment

  • Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems.

  • Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with clinical leadership.

  • Complete initial training and maintain competencies as current and up to date for all trained assays.

  • Wear appropriate PPE as required and comply with safety rules and regulations.

  • Follow standard operating procedures (SOP).

  • Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance as appropriate.

  • Escalate equipment issues that impact TAT or patient safety.

  • Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.

  • Perform instrument and procedural calibrations and maintenance.

  • Advises and drives progress on troubleshooting equipment issues.

  • Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action.

  • May act as trainer in place of designated trainer/training team.


Team

  • Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.

  • Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity.

  • Seen as a role model for safety behavior standards and cultural tenets.

  • Serves as a leader from the bench, demonstrating consistency in good lab practices.

Knowledge, Skills and Abilities

  • Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution

    • Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency

  • Hold a current and active American Society of Clinical Pathology (ASCP) board certification

  • Hold current and valid Clinical Laboratory Scientist licensure (Generalist or CGMBS)

  • Demonstrate a working knowledge of the general biological principles that govern DNA biology

  • Possess a strong foundational understanding of common molecular biology techniques, such as PCR/qPCR, DNA ligation, and DNA extraction 

  • Working level knowledge or ability to learn use of common molecular biology instruments; Agilent Tapestation/capillary electrophoresis, Qubit, plate readers, thermocyclers and other common laboratory instruments

  • Experience with implementing and performing histology processes, preferred

  • Previous experience handling human biological materials is required

  • Working knowledge of how to safely operate in a BSL-2 environment is required

  • Previous experience handling, processing, and extracting DNA from biological specimens is required


Working Conditions and Physical Effort


Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:  


This role is offering an hourly wage between $49.28 - 54.09 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 


The application deadline for this position is June 15, 2024.


You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Location: Boulder, Colorado, United States

About our Company:  

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.


About the Role

The Clinical Laboratory Scientist III will be responsible for performing a variety of laboratory procedures involved in end-to-end processing of biological samples to enable successful downstream next-generation sequencing (NGS). Processing will include accessioning and both manual and automated extraction, library preparation, hybrid capture, sequencing and QC steps. Under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, you will work collaboratively within the clinical laboratory leveraging your technical knowledge, skills and abilities to ensure efficient and quality results are provided to our clients and patients. The Clinical Laboratory Scientist III will also inform and participate in process improvements through ownership and leadership. This position will report to the Director of Clinical Laboratory Operations.


Responsibilities 

Technical

  • Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.

  • Provide technical guidance and oversight to licensed and non-licensed personnel for pre-analytical, analytical and post-analytical activities.

  • Interpret data and results of all analyses according to set procedures and guidelines.

  • Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.

  • Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to clinical leadership as needed.

  • Assist with research, translational research, regulated products through the execution of partnership studies and internal/external validation studies.

  • Participate as a contributing member of the clinical laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.

  • Proposes assay and process improvements and conducts improvement activities under guidance.

  • Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.

  • Participate in new or revised assay launches giving input on launch logistics as appropriate.

  • Participate in work planning initiatives and scheduling.

  • Utilize understanding of d/pFMEA, failure modes and phenotypes for the assay chemistry and instrumentation to support risk assessment and remediation.

  • Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful implementation of instrumentation into the clinical laboratory testing workflow. 

  • May operate as a General Supervisor. 


Quality, Training & Equipment

  • Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems.

  • Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with clinical leadership.

  • Complete initial training and maintain competencies as current and up to date for all trained assays.

  • Wear appropriate PPE as required and comply with safety rules and regulations.

  • Follow standard operating procedures (SOP).

  • Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance as appropriate.

  • Escalate equipment issues that impact TAT or patient safety.

  • Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.

  • Perform instrument and procedural calibrations and maintenance.

  • Advises and drives progress on troubleshooting equipment issues.

  • Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action.

  • Train internal clinical team to new instrumentation, products, processes, or assays to support successful implementation in the clinical laboratory. 


Team

  • Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.

  • Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity.

  • Seen as a role model for safety behavior standards and cultural tenets.

  • Serves as a leader from the bench, demonstrating consistency in good lab practices.

Knowledge, Skills and Abilities

  • 6+ years of relevant laboratory work experience

  • 2+ years Experience in ISO 13485/15189, GLP and or CAP/CLIA environments 

  • Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution

    • Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency

  • Hold a current and active American Society of Clinical Pathology (ASCP) board certification

  • Hold current and valid Clinical Laboratory Scientist licensure (Generalist or CGMBS)

  • Experience performing complex molecular biology workflows, ideally NGS workflows

  • Experience with implementing and performing histology processes, preferred

  • Previous experience designing and performing validations and verifications, process development and process-directed documentation

  • Experience in complex problem-solving and risk management/mitigation (i.e. identify potential equipment or chemistry failures)


Working Conditions and Physical Effort


Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:  




This role is offering an hourly wage between $51.44 - 59.38 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 


The application deadline for this position is June 15, 2024.


You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Location:  Remote in the United States

About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role:  The Director, Business Development is responsible for business development activities for Foresight Dx and is accountable for revenue generation from biopharma partners and research institutions. Foresight Dx customers are biopharmaceutical companies or research institutions seeking precision oncology assays to evaluate MRD and a partner to execute diagnostic projects to enable regulatory filings. This individual also will monitor execution of some contracted work to ensure quality and provide a high level of customer satisfaction.

What You Will Bring:

  • Bachelor's Degree

  • Combined 5 years business development and sales experience selling a complex product or service

  • Previous experience in a healthcare products company (therapy, diagnostics or medical devices)

  • Proven track record in achieving company goals through creation of strategic partnerships, including pre-contract negotiations and post-contract alliance management.

  • Experience with the establishment of contracts, development of pricing strategies and monitoring contract fulfillment.

Preferred:

  • Bachelor’s Degree in a life sciences discipline

  • Master of Business Administration or a relevant life sciences PhD

  • Prior corporate development, tactical and/or strategic marketing experience

  • Previous experience in the companion diagnostics field or biopharma partnering

What You Will Do:

  • Lead business development for a portfolio of current and potential biopharma partners, including contract and in some cases alliance management activities for customers located potentially globally.

  • Create objectives and key results as well as account strategies needed to close revenue generating contracts for customers ranging from biopharma companies to research institutions.

  • Partner with marketing to support the voice of the customer for all marketing activities. Ensure strong handoff from marketing efforts to generate awareness in Foresight Dx and belief in Foresight Dx solutions to business development activities to reach and secure new customers.

  • Develop, maintain and execute a strong pipeline of new business and qualified leads.

  • Maintain a good understanding of the trends in the biopharmaceutical industry and how they impact the Foresight Dx and diagnostics broadly. Additionally, leverage these insights to support the strategic plan of the organization.

  • Follow emerging business trends and economic requirements of the biopharmaceutical industry as well as screen and recommend key target companies.

  • Work with project and lab personnel to ensure projects can be fully supported and delivered on quality and time.

  • Closely collaborate with all functions to align Foresight Dx biopharma partnership activities with the capabilities of the organization.

  • May manage staff as the business needs grow; provide staff with coaching, training, and opportunities to develop skills, and give ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

  • Other duties as assigned by management.

This role is offering a salary between $210,000-240,000, and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 

The application deadline for this position is April 15, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Location: On site or hybrid schedule in Boulder, Colorado, United States


About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.


About the Role:  The Senior Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight’s GCP/CLIA laboratory. This role will operationalize quality systems, leveraging your technical knowledge, skill and abilities to ensure regulatory compliance. The Senior Manager, Quality Assurance will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards. This position will report to the Director of Quality. 


What You Will Bring:

  • Bachelor’s degree in a scientific field

  • Minimum of 7 years of experience in an FDA/ISO-regulated environment, including experience with Clinical regulations (CAP/CLIA/NYSDOH for high-complexity laboratory testing) 

  • Ability to define, scope, map and implement new or improved documented quality processes

  • Knowledge of BSL-2 laboratories

  • Experience with LIMS, eQMS, and paper-based quality systems

  • Excellent verbal and written communication skills, as well as attention to detail and organizational skills


What You Will Do:

  • Implement and maintain the necessary programs to support the Quality Policy, the Quality System, and continuous improvement initiatives to ensure compliance with ISO15189, FDA GCP and GLP, CAP/CLIA, NYSDOH, and other US and international regulatory standards.

  • Ensure that Quality System elements are in compliance with Clinical, ISO, and FDA regulations, and help to create and/or drive improvements to Policies and Standard Operating Procedures.

  • Oversee FDA-regulated design control activities to ensure effective and compliant execution for the Foresight assay and software design.

  • Manage design control documentation required for effective DHF/DHR/DMR management. 

  • Organize and lead the management of NCR/CAPA, complaints, management review, laboratory support, services, processes, reporting, supplier management, document and records control, training, audits, and other QMS responsibilities.

  • Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality.

  • Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate.

  • Host and provide front-room representation during internal and external audits, including CAP, FDA, ISO, and biopharmaceutical companies.

  • Manage audit program, including schedule adherence, reviewing audit reports, and following up on required actions.

  • Maintain the eQMS and provide document control support.


Team

  • Communicate and interact with all levels of the organization including Executive Leadership

  • Work effectively with cross-functional teams for problem-solving, product and process improvement

  • Cultivate, build and maintain positive and collaborative relationships within the Quality team and cross-functionally

  • Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific, and performance standards to ensure the highest quality for sample integrity

  • Leverage leadership skills to motivate, inspire and train staff to engage in quality and adhere to regulations


This role is offering a salary between $155,000-169,000 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 


The application deadline for this position is April 5, 2024


You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Location: Boulder, Colorado, United States

About our Company: 

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.


About the Role:

Senior Scientists in the Research Department at Foresight Diagnostics are responsible for spearheading design and development of research and regulated product studies to include focus areas of solid tumor and next generation products with support for follow up product validation. Senior Scientists must be creative, solutions-oriented, and professional with strong experience developing NGS assays in a regulated environment. Senior Scientists will work cross functionally, with departments such as clinical operations, bioinformatics, production, to create and optimize wet and dry laboratory processes, and to generate data and analyses to support performance claims. This position reports to the Director of Research.

Responsibilities 

  • Generate and maintain meticulous and consistent documentation of all work performed, in compliance with Good Laboratory Practices and Quality Systems requirements as appropriate.

  • Rigorously adapt the scientific method and hypothesis testing to company priorities and the product development context.

    • Using deep technical knowledge of NGS chemistry, identify and initiate efforts to improve performance and efficiency, and reduce error in assay steps;

    • Oversee the design, planning, execution, and reporting of multiple studies supporting different stages of the product development life cycle;

    • Generate increasingly sophisticated data visualizations and statistical analyses from increasingly complex NGS data sets;

    • Understand the rationale and analytical approach for studies and draw conclusions and propose next steps based on evidence;

    • Concisely and effectively communicate study results with audience-specific tailoring and integration of Foresight’s values.

  • Participate in cross-functional projects as a technical SME and clear communicator, working frequently with other departments to complete product life cycle deliverables:

    • Collaborate in building project timelines and defining deliverables;

    • Collaborate in technology transfer between work streams and product contexts;

    • Proactively communicate potential risks and issues;

    • Support others in troubleshooting technical issues and propose next steps;

    • Provide technical input and representation to support cross-functional deliverables such as risk assessments, publications, and regulatory submissions.

  • Serve as a formal or informal technical mentor:

    • Train junior members on all aspects of core FDx assays, study design, data analysis, reporting, troubleshooting, and effective scientific communication;

    • Guide the day-to-day work of multiple team members as needed;

    • Lead teams to deliver projects on time and budget;

    • May operate as a reporting leader for junior team members.

  • Design technology-driven processes to enhance efficiency, quality, and accelerate productivity of product development teams. 

Skills and Qualifications

  • Required

    • B.S., M.S., or Ph.D. in Molecular Biology, Biochemistry, or a related field

    • Minimum 7 years of industry experience in regulated NGS assay development

    • Expertise in common molecular genetics techniques, especially library preparation and targeted enrichment for NGS

    • Expertise creating data visualizations, text, and/or presentations that clearly communicate complex scientific information and concepts for a broad audience

    • Willingness to regularly perform benchwork

    • Ability to troubleshoot complex technical issues

    • High emotional intelligence and self-awareness

    • High attention to detail, time management, and risk

    • Evidence-driven, confident, and decisive cross-functional communication

    • Ability to adapt in a fast-paced environment

  • Preferred

    • Subject matter expertise in genomics, molecular diagnostics, and/or liquid biopsy

    • Familiarity with regulatory requirements for assays with different types of risk profiles and the importance of managing risk in product development

    • Understanding of cancer biology and clinical processes

    • Experience in the product development processes from feasibility to validation

    • Experience leading a technical team

    • Proficiency in R, Python, bash, or similar

Physical Requirements

  • This is a site-required position.

  • This position requires the individual to wear and work in personal protective equipment.

  • This position requires that the individual is able to lift a minimum of 25 lbs.

  • Substantial movements (motions) of the wrists, hands, and/or fingers are required.

  • The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures, writing and reviewing documents, and pipetting small volumes of clear liquids.

This role is offering a salary between $123,000-138,000 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 

The application deadline for this position is June 15, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Remote, Company based in Boulder Colorado, United States

About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.   

About the Quality Team:  Come join a growing Quality team that is eager to incorporate Quality principles into the framework of an entire organization!  We are building intuitive compliance systems needed to ensure that regulatory requirements are met while helping to ensure the scalability of our operations.   

About the Role:  The Software Design Quality Engineer will be responsible for ensuring software systems supporting cross functional teams and Foresight’s products are developed, implemented and maintained in compliance with ISO27001, IEC62304, ISO13485, and clinical regulations (CAP, CLIA, ISO15189). This position will work cross functionally with internal members of the clinical laboratory, R&D, IVD, bioinformatics, product development, and regulatory teams predominantly on software quality requirements, but may also be asked to participate in additional QMS activities to support cross-functional projects and requirements.  Externally, this position will participate in audits with our regulatory bodies. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Director of Quality.

What You Will Bring:

  • 3-5 years of experience working in a software quality-related role in a regulated environment, such as FDA, ISO, or CAP/CLIA

  • Bachelor’s degree in software engineering, computer science, information technology, or related.

  • Experience executing IEC62304 software design lifecycle development in conjunction with ISO13485 design control requirements

  • Experience defining process requirements for, and conducting, software validation 

  • Demonstrated ability to define and implement a compliant development process 

  • Proven ability to deliver actionable results to complex problems

  • Ability to deliver on end-to-end projects with a high level of autonomy

  • Exceptional interpersonal skills with ability to work inclusively and collaboratively with a diverse population

What You Will Do:

  • The engineer is responsible for various design quality engineering functions in support of development such as risk management, requirements and test reviews, as well as other design controls activities on Medical Device software

    • This is inclusive of design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting

  • Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation

  • Ensure that design controls are compliant with IEC 62304 and other regulatory guidances 

  • Create and revise standard operating procedures (SOPs), as needed, to define software quality requirements and release readiness operations, and shepherd these documents through the design and documentation control processes

  • Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development, and testing

    • Develop risk analysis tools and risk management plans for Foresight’s suite of software systems

  • Closely monitor, maintain, and improve the efficiency of processes via regular audits and internal reporting 

  • Support and ensure adherence to Foresight’s product and cybersecurity processes

  • Resolve end user issues via investigation and resolution, to include management of the NCR and CAPA processes and metrics

  • Ensure all software quality practices are in compliance with Foresight’s SOPs and applicable regulations 

  • Support the development and implementation of comprehensive test plans and test cases to assess compliance of products outlined in the product roadmap and coordinate with cross functional teams on timely remediation 

  • Lead cross functional collaboration in designing and implementing validation plans for Foresight’s suite of software systems 

This is a remote or onsite position offering a salary between $112,000-135,000, generous equity, along with medical, dental and vision benefits. You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now

Location: Boulder, Colorado, United States

About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.     

About the Role:  The Vice President of Human Resources will be responsible for leading and managing the overall HR function for the company. This includes developing and implementing strategic HR initiatives, creating and implementing policies and procedures, and managing the recruitment and selection process for all positions within the company. The Vice President of Human Resources will act as a strategic business partner to the senior leadership team, providing guidance and support on all HR-related matters. The Vice President of Human Resources will be responsible for creating and maintaining a positive and productive work environment in alignment with the company’s culture that promotes employee engagement, retention, and satisfaction. In addition, the Vice President of Human Resources will contribute as a corporate leader of the company, engaging in strategic planning, execution, evaluation and communication of corporate initiatives. This position reports directly to the Chief Operating and Compliance Officer.

What You Will Bring:

  • Bachelor's degree in human resources management or a related field; legal experience is a plus. 

  • A minimum of 8-10 years of experience in human resources management, with at least 5 years of experience in a senior-level HR role.

  • Proven track record of successfully leading and managing the HR function in start up organizations, health care or biotech industry preferred.

  • Strong knowledge of federal, state, and local labor laws.

  • Excellent communication, leadership, and interpersonal skills.

  • SPHR or SHRM-SCP certification is a plus.

  • Project management and change management skills.

  • Excellent analytical, data interpretation and problem solving skills.

  • Business acumen, financial literacy, and clear understanding of effective business operations.

  • Experience in employee relations, compliance, recruitment, and employee development are essential.

What You Will Do:

  • Support the overall strategic goals and objectives of the company by aligning HR initiatives with the company's mission, vision, and values.

  • Attract, hire, and retain top talent for the company. This includes developing and implementing effective recruitment and selection processes, as well as creating and maintaining a positive and productive work environment in alignment with the company’s culture that promotes employee engagement, retention, and satisfaction.

  • Improving employee performance and productivity by managing the performance management process, including goal setting, performance evaluations, and career development plans.

  • Supporting employee development and growth by implementing and managing employee training and development programs, including onboarding, employee orientation, and ongoing professional development.

  • Coordinate external and develop internal leadership training programs to support continuing education for senior and functional leadership.

  • Managing and controlling the HR budget, including forecasting, tracking, and reporting on HR expenses.

  • Ensuring compliance with federal, state, and local labor laws, including providing guidance on immigration, worker's compensation, and other HR-related laws.

  • Managing and resolving complex employee relations issues, investigations, and complaints.

  • Collaborating with senior leaders and other stakeholders to identify and address organizational development needs, including succession planning and talent management.

  • Developing and implementing employee engagement and recognition programs to increase employee satisfaction and retention.

  • Conducting research and providing data analysis on industry best practices and trends to inform and drive HR strategy and decision-making.

  • Collaborate with local partners, such as the University system to develop internship programs and successful academic to industry transitions for entry level talent. 

  • Act as a strategic partner to the COO and other senior leaders, providing guidance and support on all HR-related matters.

  • Continuously monitor and improve HR processes, procedures and policies to ensure they are in line with the company's goals and objectives.

  • Develop, implement and track HR KPIs for Corporate Operations monthly reporting.

  • Manage and develop the HR team. 

  • Contribute to leadership of the organization, including strategic planning, decision making, and execution of critical corporate objectives.

This role is offering a salary between $215,000-260,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 

The application deadline for this position is May 15, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Apply Now