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 jnj.com

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Job Function:

Project/Program Management Group

Job Sub Function:

Project/Program Management

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson Med Tech, a member of Johnson & Johnson's Family of Companies, is recruiting for a New Product Introduction Manager. This position will be in Santa Clara, California.

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/ (https://www.jnj.com/

The NPI Manager will lead the introduction of product, material, equipment, and process changes for capital equipment in a regulated MedTech manufacturing environment. This role ensures that engineering changes, product upgrades, and new subsystem introductions are executed with full compliance, robust validation, and seamless integration into production.

You will partner across R&D, Manufacturing Engineering, Quality/Regulatory, Supply Chain, and Service teams to ensure products and processes meet stringent safety, quality, and reliability requirements while supporting operational readiness for new configurations and ongoing changes.

Key Role Responsibilities

1. Change Management & Build Readiness

Manage engineering changes (ECO/ECR) across mechanical, electrical, software, and consumable interfaces associated with capital equipment systems.

Plan and oversee prototype, pilot, and production builds of capital equipment, coordinating cross‑functional readiness across materials, equipment, tooling, documentation, and test systems.

Own readiness reviews for changes impacting hardware, embedded firmware, manufacturing processes, and service procedures.

Identify, escalate and problem-solve implementation risks.

2. Cross‑Functional Leadership

Lead cross-functional NPI teams including R&D, Manufacturing, Quality, Regulatory, Supplier Quality, Field Service, and Program Management.

Ensure alignment on risk mitigation strategies, validation requirements, and manufacturing readiness criteria for every product or process change.

3. Material, Equipment & Process Integration

Manage BOM updates and ensure accurate translation from engineering design (EBOM) to manufacturing configuration (MBOM).

Support supplier qualification, material readiness, and process validation for new or modified components, subassemblies, and instrumentation.

Evaluate equipment, tooling, and automation requirements needed to support new product variants or process updates

Ensure manufacturing lines meet throughput, quality, and compliance requirements.

4. Quality, Compliance & Continuous Improvement

Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, IEC 60601, and other relevant standards.

Support design risk assessments (dFMEA), process risk evaluations (pFMEA), and integration into change approval processes.

5. Communication, Documentation & Reporting

Maintain and communicate NPI timelines, open issues, and cross‑functional deliverables.

Provide executive‑level reporting on program readiness, risks, mitigation actions, and production scale‑up status.

Ensure all documentation (work instructions, test procedures, service manuals, acceptance criteria, traceability packages) is updated and released prior to deployment.

Qualifications

Required Skills

• Bachelor’s degree in Mechanical, Electrical, Biomedical, Systems, or Manufacturing Engineering or related field.
• 5–10+ years in NPI, Manufacturing Engineering, or Technical Program Management for complex electromechanical products such as MedTech Capital Equipment, Robotics, Aerospace or Automotive.
• Experience with manufacturing quality systems in regulated environments.
• Demonstrated success running prototype/pilot builds, validation phases, and manufacturing transitions for complex electromechanical systems.
• Strong understanding of BOM management, ECO/ECR processes, verification/validation planning, and change control discipline.
• Ability to lead cross‑functional teams and manage multiple complex programs simultaneously.

Preferred Skills

• Experience with electromechanical/robotic capital equipment, surgical systems, diagnostic platforms, imaging equipment or other MedTech products.
• Familiarity with IQ/OQ/PQ methodologies and equipment qualification best practices.
• Experience working in regulated environments under FDA 21 CFR 820, ISO 13485
• Knowledge of PLM systems (Agile, Arena, Windchill)
• Background integrating firmware/software-controlled hardware in regulated manufacturing.
• Lean/Six Sigma certification or experience with process capability improvement.
• Strong communicator capable of influencing teams at all organizational levels.
• Able to translate complex technical challenges into structured plans and actions.
• Highly organized with strong judgment in balancing speed, compliance, and risk mitigation.
• Comfortable in an environment that requires decisive action, technical rigor, and cross‑functional alignment.

Other

• This position will require up to 10% of domestic travel
• The attendance policy for this position is Fully Onsite
• The anticipated pay range for this position is $118,000.00 to $179,035.00

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$118,000.00 - $203,550.00

Additional Description for Pay Transparency: