Staff Product Development Engineer (Medical Devices)

Location: On-site in Santa Clara, California, United States

Salary: $134,000–$231,150 per year, plus eligibility for performance-based bonuses and long-term incentives.

Company

Johnson & Johnson MedTech develops healthcare technologies, including robotic surgical platforms and connected digital solutions designed to improve clinical outcomes.

What you will do

• Lead hardware product development from concept through commercialization, translating clinical and user needs into requirements and specifications.
• Lead phase reviews and design reviews for endoscopic and disposable medical devices.
• Define, develop, prototype, and integrate devices with cross-functional design teams.
• Own user, system, and subsystem requirements, including rationale, acceptance criteria, verification strategies, and bidirectional traceability.
• Lead hazard analyses, FMEAs, design-change risk assessments, and post-market risk activities.
• Develop and review design verification and validation strategies, test results, risk controls, and regulatory evidence.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• At least 8 years of product development experience in medical devices or another regulated industry.
• Experience with Design Control, requirements management, risk management, design verification, and product development through commercialization.
• Knowledge of medical device development processes, including ISO 14971, Design Verification and Validation, and regulatory compliance.
• Experience with technologies or processes such as metal injection molding, precision machining, lamination, molding, or extrusion.
• Hands-on experience integrating hardware, disposables, software, and capital equipment, and using Jama or an equivalent requirements and risk management tool.

Nice to have

• Experience with SAP Product Lifecycle Management.
• Experience in project management methodology, vendor management, feasibility studies, or contract management.
• Experience coaching teams and influencing senior leadership or external partners.

Culture & Benefits

• Collaborative work across R&D, Clinical Engineering, Medical Safety, Quality, Regulatory, Manufacturing, and Product Management.
• Medical, dental, vision, life insurance, disability, business accident, and group legal insurance may be available.
• Eligibility for pension and 401(k) savings plans.
• Vacation, sick time, holiday pay, and work, personal, and family time benefits.
• Inclusive work environment and equal employment opportunity commitment.