Product Introduction Manager

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 Med Tech, 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.

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Project/Program Management Group

Project/Program Management

Professional

Santa Clara, California, United States of America

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.

The NPI Manager will lead the introduction of product, material, equipment, and process changes for capital equipment in a regulated Med Tech 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.

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, escape and problem-solve implementation risks.

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.

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.

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.

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.

• 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…