Note: The job is a remote job and is open to candidates in USA. DermaSensor, Inc. is a fast-growing medical device company focused on empowering healthcare professionals with solutions to detect skin cancer. The Product Development and Quality Engineering Manager will lead cross-functional product development and quality engineering initiatives, ensuring compliance with regulatory standards and managing software and hardware development projects.
Responsibilities
- 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
- 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
Skills
- 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
- 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
Company Overview