Director, R&D Hardware Engineering

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

R&D Digital

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

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.

Leadership & Strategy

• 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.

Product Development

• 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.

Execution & Delivery

• 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.

Stakeholder Management

• 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.

Qualifications

Required:

• 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.

Preferred:

• Master’s or Ph.D.