Director of R&D Engineering – Class II Electromechanical Medical Devices

Summary

A growing medical device organization is seeking a Director of R&D Engineering to lead development of Class II electromechanical hardware/software systems from concept through commercialization. This role oversees multidisciplinary engineering execution across mechanical, electrical, embedded software, manufacturing engineering, and quality, ensuring compliant product development aligned with regulatory and business objectives. The position plays a central role in shaping product strategy, scaling engineering capabilities, and driving successful product launches in regulated environments.

Responsibilities

• Lead end-to-end development of Class II electromechanical medical devices from concept through verification, validation, and production release
• Manage and mentor cross-functional teams across mechanical, electrical, embedded software, production engineering, and quality engineering
• Establish and maintain design control processes aligned with FDA and ISO 13485 requirements
• Drive system architecture decisions across hardware, firmware, and software platforms
• Oversee product verification, validation, and risk management activities (DFMEA, PFMEA, hazard analysis)
• Partner with Regulatory Affairs to support 510(k) submissions and technical documentation strategy
• Ensure effective transfer from R&D to manufacturing, including DFM/DFA readiness and supplier engagement
• Collaborate with Operations to scale production and resolve technical challenges during ramp
• Implement engineering best practices, development workflows, and phase-gate execution frameworks
• Manage engineering budgets, timelines, and resource allocation across multiple concurrent programs
• Support CAPA, complaint investigations, and post-market engineering activities
• Contribute to product roadmap planning alongside executive leadership and commercial stakeholders

Requirements

• 12+ years of experience developing regulated electromechanical medical devices
• 5+ years leading multidisciplinary engineering teams
• Demonstrated experience delivering Class II hardware/software medical devices through full product lifecycle
• Strong knowledge of FDA design controls (21 CFR 820) and ISO 13485
• Experience supporting or leading 510(k) submissions
• Background integrating hardware, embedded firmware, and system-level software architectures
• Experience overseeing production engineering and manufacturing transfer activities
• Working knowledge of risk management frameworks (ISO 14971, DFMEA, PFMEA)
• Experience collaborating with contract manufacturers and external suppliers
• Proven ability to scale engineering organizations and processes in growth-stage environments

Preferred

• Experience with connected or digitally enabled medical devices
• Exposure to cybersecurity considerations for medical device systems
• Experience supporting global regulatory submissions
• Advanced degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field