Johnson & Johnson MedTech · 8 hours ago
Director, R&D Hardware Engineering
Danvers, MA
Full-time
Onsite
Director/Executive
$160K/yr - $276K/yr
12+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to improving patient outcomes through advanced medical technologies. The Director of Hardware Engineering will lead the strategy and execution of hardware platforms for next-generation medical devices, overseeing engineering teams and ensuring compliance and innovation throughout the product development process.
Hospital & Health Care
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
Qualification
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. 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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401k)
Long-term incentive program
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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