Director, R&d Hardware Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

Director of Hardware Engineering at Johnson & Johnson, leading the strategy, development, and execution of hardware platforms for next-generation medical devices, including controllers and critical hardware products. Requires expertise in hardware systems engineering, medical device product development, and leadership of cross-functional teams from concept to commercialization.

What you'd actually do

  1. Define and execute Abiomed’s hardware engineering vision for controller platforms (AIC) and other critical hardware systems.
  2. Build, mentor, and develop high-performing teams of electrical, mechanical, and systems engineers.
  3. Lead end-to-end development of AIC hardware and future controller platforms, from feasibility through launch.
  4. Drive system architecture decisions balancing safety, usability, scalability, and reliability.
  5. Manage project resources, schedules, and budgets to meet business objectives.

Skills

Required

  • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or Computer Engineering
  • 12+ years of experience in hardware/system engineering
  • 5+ years in leadership roles
  • Proven track record in Class II/III medical device development, including IEC 60601 compliance
  • Expertise in hardware architecture, electronics, electromechanical integration, and embedded platforms
  • Strong understanding of FDA design control, ISO 13485, and risk management practices
  • Demonstrated ability to lead cross-functional engineering teams and deliver complex programs

Nice to have

  • Master's or Ph.D. in Engineering or related technical discipline
  • Experience with life-sustaining devices or critical care capital equipment
  • Familiarity with human factors engineering and usability standards (IEC 62366)
  • Experience integrating digital health, connectivity, or cybersecurity features into medical hardware
  • Strong leadership presence with ability to influence executive and clinical stakeholders

What the JD emphasized

  • Class II/III medical device development
  • IEC 60601 compliance
  • FDA design control
  • ISO 13485
  • risk management practices