DermaSensor, Inc Product Development and Engineering Manager Remote · Full time Company website

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DermaSensor Inc. is a fast-growing, Miami-based medical device company focused on empowering healthcare professionals with clinically proven solutions to efficiently detect skin cancer using the latest advancements in medical-grade technology. Our flagship product, the FDA-cleared DermaSensor™ medical device, is a cost-effective handheld solution that combines artificial intelligence and spectroscopy to assess suspicious skin lesions for skin cancer risk in just seconds. By enabling real-time, accurate assessments, DermaSensor aims to dramatically improve early detection rates, increase access to vital healthcare, and ultimately save lives. Join us as we reshape the future of healthcare with groundbreaking technology designed to make a lasting impact on patient care and outcomes.

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.