DermaSensor, Inc. · 3 weeks ago
Product Development and Engineering Manager
Miami-FTL Area
Full-time
Hybrid
Senior Level
7+ years expDermaSensor, Inc. is seeking a dynamic, detail-oriented leader to manage cross-functional product development and quality engineering initiatives. The role involves overseeing software development and sustaining engineering activities while ensuring compliance with global regulatory expectations and managing quality engineering functions.
BiotechnologyHealth CareMedicalMedical DevicePrimary and Urgent Care
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, including DHF, DMR, and engineering change orders (ECOs), to ensure 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
Qualification
Required
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
Preferred
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
Close attention to detail, 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
DermaSensor, Inc.
Now cleared by the U.S.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$51.93MKey Investors
Ceros Capital MarketsMedTech Innovator
2025-10-02Series B· $16M
2025-03-16Series Unknown
2024-12-04Undisclosed· $8.93M
Leadership Team
Cody Simmons
Co-Founder & CEO
Recent News
2025-12-02
Precedence Research
2025-11-25
Company data provided by crunchbase