New Product Introduction Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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Johnson & Johnson Med Tech a member of Johnson & Johnsons 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 ( 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 crossfunctional 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. CrossFunctional 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 crossfunctional deliverables.

Provide executivelevel reporting on program readiness risks mitigation actions and production scaleup status.

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

Qualifications

Required Skills

• Bachelors degree in Mechanical Electrical Biomedical Systems or Manufacturing Engineering or related field.
• 510 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 crossfunctional 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 crossfunctional 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 $118000.00 to $179035.00

At Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds 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 or contact AskGS to be directed to your accommodation resource.

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