Director, R&D Hardware Engineering

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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 thats 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 Director Hardware Engineering will lead the strategy development and execution of hardware platforms that power Abiomeds 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 Abiomeds business strategy.

Leadership & Strategy

Define and execute Abiomeds 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 :

Bachelors 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 :

Masters 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $160000.00 to 276000.00

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar / performance year. Bonuses are awarded at the Companys discretion on an individual basis. 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 Companys consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Companys 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. For additional general information on Company benefits please go to : - This job posting is anticipated to close on November 30 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

Required Skills : Preferred Skills :

Required Experience :

Director

Key Skills

Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 160000 - 276000