Foresight Diagnostics is seeking a Vice President, Product Software to lead the product technology lifecycle for our regulated software products and services. You will be responsible for driving compliance and implementing the strategic vision for the software critical to our diagnostic mission, encompassing technical leadership, regulatory oversight, and risk management.
What You'll Do
- Ensure cross-functional teams execute the software development lifecycle, adhering to requirements management, design, development, testing, and release.
- Collaborate with Regulated Assay Development, Regulatory, Software Systems Engineering, and Quality to integrate bioinformatic and software innovations into diagnostic tools.
- Support the development and validation of algorithms and software solutions for medical device applications.
- Develop and implement comprehensive software validation strategies, including risk management, aligned with FDA, ISO, and IEC 62304 standards.
- Oversee the creation and maintenance of system architecture and all validation documentation, including validation plans, protocols, and reports.
- Collaborate with leadership to oversee software risk management activities, including hazard analysis and risk assessment.
- Maintain detailed documentation throughout the software lifecycle for compliance and audits.
- Partner with teams to prepare technical documentation and regulatory submissions such as 510(k) or PMA and participate in FDA interactions.
- Participate as a subject matter expert in interactions, reviews, or audits with government authorities or partners.
- Manage the product software backlog, prioritizing features based on roadmap, user needs, and business value.
- Stay current with advancements in bioinformatics and medical device software to drive innovation and ensure regulatory compliance.
- Provide technical, strategic, and career guidance to the product technology team.
- Act as a software subject-matter expert in internal strategy discussions and external collaborations.
- Drive cross-functional initiatives, ensuring alignment with organizational goals and regulatory requirements.
What We're Looking For
- Bachelor’s or MS in Engineering, Computer Science, or a related field.
- 10+ years of experience in the medical device industry with strong knowledge of software validation, quality systems, and compliance.
- Deep understanding of FDA regulations such as 21 CFR Part 820.
- Familiarity with relevant FDA guidance documents for medical device software and SaMD.
- Experience building secure software solutions compliant with HIPAA and FDA cybersecurity guidance.
- Experience implementing robust risk management processes following standards like ISO 14971.
- Expert-level experience with software validation and verification processes, including writing and executing test protocols.
- Proven track record of working with regulatory bodies such as the FDA, including direct interaction.
- Strong interpersonal and communication skills for effective cross-functional teamwork.
- Successful history of coaching, mentoring, and supporting team members in their career growth.
- Adaptable to fast-paced, dynamic work environments and shifting demands.
Nice to Have
- Strong background in product software engineering in molecular diagnostics or the medical device industry.
- Extensive experience with FDA submissions and leading cross-functional teams to deliver compliant product software.
- Experience interacting directly with the FDA.
Team & Environment
You will report to the Head of Product. The company culture is dynamic and fast-paced, promoting professional development and upward mobility for high-performing employees.
Benefits & Compensation
- Salary: $275,000 + equity offerings
- Paid vacation, sick time, and parental leave (if applicable)
- Medical, dental, vision, life, disability coverage
- Flexible spending accounts
- 401k with company match
Work Mode
This role offers a hybrid work mode. You can work remotely, hybrid, or on-site in Boulder, Colorado, United States.
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.
