Staff Product Development Engineer, I&A

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Annual performance bonus

Healthcare benefits

Retirement plan / 401(k)

On-site / Santa Clara location

Job summary

Johnson & Johnson MedTech is recruiting for a Staff Product Development Engineer, Instruments & Accessories in Santa Clara, CA. You will translate clinical needs into hardware requirements and drive risk management across Monarch Instruments and Accessories, leading cross‑functional teams through design control processes.

The role emphasizes design verification, risk management, and collaboration with Regulatory, Quality, and manufacturing teams to ensure compliant product development and

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• 8+ years of product development experience in medical devices or other regulated industries.
• Strong experience with Design Control and cross-functional product development from concept through commercialization.
• Demonstrated experience translating user, clinical, business, and regulatory needs into clear, testable requirements.
• Hands‑on experience with requirements and risk management tools such as Jama (or equivalent).
• Excellent communication, collaboration, and influencing skills across cross‑functional teams and leadership.

Responsibilities

• Lead hardware design development by translating clinical and user needs into requirements and specifications from concept through commercialization.
• Lead phase reviews and design reviews, and provide technical leadership for the development of endoscopic and disposable medical devices.
• Partner with design teams to define, develop, prototype, and integrate devices through all phases of development.
• Ensure design outputs, design verification activities, and risk controls are defined and executed to support regulatory submissions and product commercialization.
• Own creation, management, and traceability of user, system, and subsystem requirements.
• Lead system-level risk management activities including hazard analyses and FMEAs.
• Develop and support design verification and design validation strategies.
• Partner with R&D, Clinical Engineering, Medical Safety, Quality, Regulatory, Manufacturing, and Product Management teams.

Skills

Design Control

Requirements management

Risk management

Cross-functional collaboration

Regulatory compliance

Mechanical design

Education

Bachelor’s degree in Biomedical Engineering

Tools

Jama

PLM SAP

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: R&D Mechanical Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Santa Clara, California, United States of America

Job Description: Johnson & Johnson MedTech is recruiting for a Staff Product Development Engineer, Instruments & Accessories within our MedTech Surgery organization. The location for this position is Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes. Johnson & Johnson MedTech is developing a robotic surgical platform that will set a new standard for the modern OR and transform the surgical experience. OTTAVA is designed as a multi-specialty soft-tissue surgery robot, activating the benefits of AI/ML, connecting health data inside the operating room and out.

The Staff Product Development Engineer, Instruments & Accessories is responsible for translating clinical and user needs into robust hardware design, and drive requirements and risk management activities as part of product development in Design Control across Monarch Instruments and Accessories.

Key Responsibilities

Design Control & Hardware Product Development

Lead hardware design development by translating clinical and user needs into requirements and specifications from concept through commercialization, ensuring compliance with Design Control procedures throughout the product lifecycle.

Lead phase reviews and design reviews, and provide technical leadership for the development of endoscopic and disposable medical devices.

Partner with design teams to define, develop, prototype, and integrate devices through all phases of development.

Ensure design outputs, design verification activities, and risk controls are appropriately defined and executed to support successful regulatory submissions and product commercialization.

Requirements Management

Own creation, management, and traceability of user, system, and subsystem requirements.

Lead development of requirements rationale, acceptance criteria, and verification strategies.

Ensure bidirectional traceability between user needs, requirements, risks, design outputs, and verification activities.

Risk Management

Lead system-level risk management activities including hazard analyses and FMEAs.

Ensure risk control measures are appropriately linked to requirements and verification evidence.

Lead risk assessments associated with design changes, sustaining activities, and post-market feedback.

Verification & Validation

Develop and support design verification and design validation strategies.

Ensure requirements are objective, measurable, and verifiable.

Review test results and assess impacts to performance, safety, and regulatory compliance.

Cross-Functional Collaboration

Partner with R&D, Clinical Engineering, Medical Safety, Quality, Regulatory, Manufacturing, and Product Management teams to ensure products are safe, effective, and compliant throughout the product lifecycle.

Mentor teams on requirements development and risk management best practices.

Qualifications Required Knowledge/Skills, Education, And Experience:

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.

8+ years of product development experience in medical devices or other regulated industries (e.g., aerospace, automotive).

Demonstrated expertise in key product design technologies (e.g., metal injection molding, precision machining) or manufacturing processes (e.g., lamination, molding, extrusion) with the ability to evaluate and balance technical design approaches against clinical, manufacturability, quality, and business requirements to drive optimal hardware design.

Strong experience with Design Control and cross-functional product development from concept through commercialization.

Demonstrated experience in requirements management, risk management, and design verification.

Proven experience translating user, clinical, business, and regulatory needs into clear, testable, and traceable requirements.

Strong understanding of medical device development processes, including ISO 14971, Design Verification & Validation, and regulatory compliance.

Hands‑on experience in developing, testing and iterating systems that integrate hardware, disposables, software, and capital equipment.

Hands‑on experience with requirements and risk management tools such as Jama (or equivalent).

Excellent communication, collaboration, and influencing skills, with the ability to effectively engage cross‑functional teams, senior leadership, and external partners.

Strong organizational and project management skills, with the ability to prioritize and manage multiple projects simultaneously.

Ability to work on‑site at the Santa Clara, CA location.

The anticipated base pay range for this position is $134,000.00 to $231,150.00 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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s 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 Company’s consolidated retirement plan (pension) and savings plan (401(k)). 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 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: https://www.careers.jnj.com/employee-benefits 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, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills: Design Control Process, Design Reviews, Design Verification, Production Development, Risk Management

Preferred Skills: Coaching, Contract Management, Critical Thinking, Design Thinking, Fact‑Based Decision Making, Feasibility Studies, Incident Management, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Vendor Management

The anticipated base pay range for this position is : $134,000.00 - $231,150.00

Additional Description for Pay Transparency: At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.