Job description
Job Title: Vice President, Product Software
Location: Remote, Hybrid, or On-Site 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 VP of Product Software will lead the product technology lifecycle and will be responsible for driving compliance and implementing the strategic vision for the regulated software products and services critical to Foresight’s mission. The VP of Product Software will partner with the PMO, Regulated Assay Development, Regulatory Affairs, Software Systems Engineering, Operations, and Quality leaders to develop and maintain regulated products in accordance with regulatory requirements and the software lifecycle. This is a complex role, encompassing technical leadership, regulatory compliance, risk management, and the overall quality and safety of the software throughout its entire lifecycle.
The ideal candidate will have a strong background of product software engineering in molecular diagnostics or the medical device industry, with extensive experience with FDA submissions and leading cross functional teams to deliver product software for medical device and SaMD meeting regulatory requirements and will have experience interacting directly with the FDA. This is a full-time position working standard business hours, but may require flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Head of Product.
What You Will Do
Responsible for ensuring cross functional teams supporting regulated product development execute to the software development lifecycle, including adherence to requirements management, design, development, testing and release.
Collaborate with key cross functional teams such as Regulated Assay Development, Regulatory, Software Systems Engineering, and Quality to integrate bioinformatic and software innovations into diagnostic tools and workflows.
Support the development and validation of algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards.
Develop and implement comprehensive software validation strategies to include risk management, ensuring alignment with regulatory requirements (FDA, ISO, etc.) and company standards in accordance with IEC 62304 Medical device software - Software life cycle processes.
In collaboration with Software Systems Engineering leadership, oversee the creation and maintenance of system architecture and all validation documentation, including validation plans, protocols, test scripts, and reports to ensure compliance to regulatory standards.
Collaborate with Software Systems Engineering, Regulatory, and Quality leadership to oversee software risk management activities, including hazard analysis and risk assessment.
Maintain detailed documentation throughout the software lifecycle, including design specifications, test results, risk analyses and traceability records for compliance and audits.
Partner with cross functional teams to prepare technical documentation, reports, and regulatory submissions such as 510(k) or PMA and participate in FDA interactions.
Participate as a product software subject matter expert in routine interactions, product reviews, or audits with government authorities, notifying bodies, or partners and co-lead resolution strategies to address gaps or issues raised.
Manage the product software backlog, prioritizing features and enhancements based on the product roadmap, user needs, business value, and technical feasibility.
Through proactive, strategic relationships with external stakeholders, stay at the forefront of advancements in bioinformatics and software for medical device development to drive innovation and to ensure all software validation activities comply with current medical device regulations and industry standards.
Provide technical, strategic, and career guidance to the product technology team, fostering a culture of excellence and continuous learning.
Act as a software subject-matter expert, representing the function in internal strategy discussions and external collaborations.
Drive cross-functional initiatives, ensuring alignment with organizational goals, timelines, and regulatory requirements.
What You Will Bring
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 practices, quality systems, and compliance requirements for a medical device (e.g., ISO 13485, IEC 62304).
Deep understanding of FDA regulations such as 21 CFR Part 820 to support design controls, quality management systems, production processes, and more. Familiar with relevant FDA guidance documents for medical device software and SaMD.
Experience with building software solutions secure against breaches, unauthorized access and cyberattacks, in compliance with HIPAA and relevant FDA guidance on cybersecurity.
Experience implementing robust risk management processes and tools throughout the software development process, following standards like ISO 14971.
Expert level experience with software validation and verification processes, including writing and executing test protocols and reports.
Proven track record of working with regulatory bodies such as the FDA (e.g., 510(k), PMA, or Breakthrough Device Designation), to include direct interaction.
Strong interpersonal and communication skills, with the ability to work effectively in a cross-functional team environment.
Successful history of coaching, mentoring, and providing feedback to support team members in their career growth.
Adaptable to fast-paced, dynamic work environments and shifting demands.
Compensation & Benefits
This role is hiring at a salary of $275,000 and is eligible for bonus and 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.
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.
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\*\*\* Apply at: Summit Human Capital \*\*\*
