Director, R&D Hardware Engineering

Johnson & Johnson • Danvers, MA

20d

About The Position

We are searching for the best talent for the Director, Hardware Engineering. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Director, Hardware Engineering will lead the strategy, development, and execution of hardware platforms that power Abiomed’s next-generation medical devices, including the Automated Impella Controller (AIC) and other mission-critical hardware products. This role requires strong technical depth in hardware systems engineering, medical device product development, and leadership skills to drive cross-functional collaboration from concept through commercialization. The Director will oversee electrical, mechanical, and systems hardware engineering teams, ensuring innovative, reliable, and compliant solutions that meet patient and clinician needs while aligning with Abiomed’s business strategy.

Requirements

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or Computer Engineering.
• 12+ years of experience in hardware/system engineering, with 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 Haves

• 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.

Responsibilities

• Define and execute Abiomed’s hardware engineering vision for controller platforms (AIC) and other critical hardware systems.
• Build, mentor, and develop high-performing teams of electrical, mechanical, and systems engineers.
• Collaborate closely with software, systems, quality, regulatory, manufacturing, and clinical teams.
• Lead end-to-end development of AIC hardware and future controller platforms, from feasibility through launch.
• Drive system architecture decisions balancing safety, usability, scalability, and reliability.
• Oversee design control activities, risk management (ISO 14971), and adherence to IEC 60601 and related standards.
• Ensure design for manufacturability, serviceability, and supply chain robustness.
• Manage project resources, schedules, and budgets to meet business objectives.
• Implement robust processes for hardware verification, validation, and lifecycle management.
• Partner with advanced technology teams to integrate emerging sensors, electronics, and connectivity into next-gen platforms.
• Serve as the technical leader and subject matter expert in executive reviews.
• Influence strategic decisions regarding product portfolio and platform investments.
• Represent Abiomed in audits, regulatory discussions, and supplier/partner engagements.

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees