Product Development and Engineering Manager

The Product Development and Quality Engineering Manager will:

Project Management 

• Lead Agile software development and documentation initiatives with internal and external engineering teams, aligned with IEC 62304 and SaMD requirements.
• Manage sustaining engineering projects and production planning with contract manufacturers, focusing on product and production improvements, cost reductions, and supply continuity.
• Maintain integrated schedules, risks, and cross-functional alignment across engineering and production teams and commercial demands.
• Facilitate sprint planning, technical reviews, and cross-functional coordination to drive on-time execution.
• Track and report on project status, risks, and key milestones to senior leadership.

Quality Engineering

• Collaborate with the Quality & Compliance Manager to maintain and improve the QMS in accordance with FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Lead requirements management to ensure all system, software, and hardware specifications are complete, testable, and aligned across disciplines.
• Drive risk management activities in accordance with ISO 14971, including updates to risk files and mitigation tracking.
• Develop and maintain V&V protocols and reports for software updates, manufacturing changes, and product improvements, including compliance with IEC 60601 and IEC 62304.
• Own traceability between design inputs, risk controls, and verification/validation (V&V) activities.
• Maintain design documentation such as DHF, DMR, and engineering change orders (ECOs), ensuring quality system alignment.
• Lead design reviews, design change control boards, and risk reviews to ensure disciplined design control processes.
• Support software and hardware root cause investigations for field issues, manufacturing deviations, or test failures.
• Lead product/production investigations and collaborate with development, product and quality system teams to identify failure modes, analyze issues, and drive corrective/preventive actions (CAPA).
• Participate in post-market surveillance activities by investigating and resolving issues raised through complaints or quality events.
• Contribute to ongoing design history file and technical document maintenance, as needed for regulatory submissions and audits.

Qualifications/Requirements:

• Bachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field).
• 7+ years of experience in medical device development, design engineering, quality engineering, or technical project management.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.
• Experience with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety & EMC).
• Proven ability to manage cross-functional software and hardware projects, ideally in a sustaining or post-market context.
• Hands-on experience with design control, requirements management, risk analysis, and V&V documentation.
• Familiarity with CAPA processes and leading root cause investigations with software and hardware teams.
• Experience working with or managing external design firms and contract manufacturers

Desired Characteristics:

• Experience with spectroscopy, electromechanical systems, embedded devices, or diagnostic tools.
• Exposure to SaMD development or integration into connected systems.
• Agile/SCRUM project management experience; PMP certification is a plus.
• Experience using tools such as JIRA, Confluence, or equivalent for design control and project tracking.
• Previous experience contributing to 510(k), De Novo, or CE Mark submissions.
• Strong analytical and problem-solving skills; structured approach to root cause investigation and design validation.
• High attention to detail with excellent documentation and organizational discipline.
• Proactive and accountable; thrives in a fast-paced, high-ownership environment.
• Collaborative, team-first mindset with the ability to lead cross-functional discussions and drive alignment.
• Excellent written and verbal communication skills, particularly in translating technical information for varied audiences.