Product Development and Engineering Manager

Derma Sensor, Inc Product Development and Engineering Manager Remote
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Derma Sensor is seeking a dynamic, detail-oriented leader to manage cross-functional product development and quality engineering initiatives. This hybrid role serves as the project manager for software development and sustaining engineering activities, while also owning critical quality engineering functions related to design control. The ideal candidate will drive hardware and software development initiatives with internal and external teams, while ensuring requirements management, risk management, and validation efforts align with global regulatory expectations.

You will work closely with our Quality & Compliance Manager to ensure overall QMS compliance.

Derma Sensor 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 Derma Sensor™ 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, Derma Sensor 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:

• 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.

• 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…