Software Design Quality Engineer

Remote, 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.