Senior Component Engineer

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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Supply Chain Engineering

Mechanical Engineering

Scientific/Technology

San Jose, California, United States of America

Johnson & Johnson is currently recruiting for a Senior Component Engineer to join our Med Tech team in San Jose, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

• Lead technical efforts in selecting, qualifying, and managing electronic or mechanical components for products.
• Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.) as well as custom injection molded or extrusion components and/or multi-component sub-assemblies.
• Support product development projects as a liaison responsible for supplier interactions and work you're doing.
• Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be implemented at supplier.
• Partner with internal design teams to assess product lifecycle design changes and develop and implement qualification test plans.
• This role requires a blend of deep technical expertise and interpersonal skills to collaborate with various teams, resolve sophisticated issues, and drive component-related strategies for the entire organization.
• Lead frequently recurring meetings with suppliers to manage engineering projects, including process validations, failure analysis, component obsolescence mitigations and manufacturing capacity increases.
• Ensure components meet technical specifications, quality standards, and regulatory.

• Collaborate with external suppliers and internal partners to develop molded components.
• Identify and evaluate injection molding suppliers.
• Plan, develop, qualify, and stabilize component development process solutions for NPD projects.
• Provide guidance on second source selection and qualify processes at second source suppliers.
• Review supplier mold tooling designs and qualification plans, write Qualification Protocols and Reports.
• Handle an approved parts list, addressing component obsolescence, and ensuring compliance with industry standards.
• Review supplier test and validation reports.
• Follow up on component related issues, FA and requalification.
• Provide technical support to advanced sourcing and R&D.
• Work with advanced sourcing in handling lifecycle issues and sourcing strategies.
• Works multi-functionally with other engineering managers, marketing, sales, and engineering personnel during the product development or revision to ensure project and/or job effectiveness.
• Identify, lead, and provide priorities and direction to external suppliers to satisfy manufacturing and development requirements for tooling, manufacturing, and inspections of direct material components.
• Responsible for ensuring robust requirements cascade from Design to Suppliers.
• Mentor staff on plastics component development.

• Bachelor’s Degree in Mechanical or Electrical Engineering or related technical degree required

• A minimum of 5 years of manufacturing process development experience, with a focus on plastics injection mould tooling and components development through process qualification required
• Possess hands‑on knowledge of mould tooling design, fabrication and assembly techniques.
• Demonstrated experience designing, improving or supporting manufacturing of injection moulded and/or extruded plastics components
• Familiar with various grades of polymers and additives inclusive of injection moulding process development
• Excellent verbal and written communication and social skills
• Experience in the Medical Device industry or medical field or other regulated environment
• Demonstrated knowledge of manufacturing principles, practices, and procedures
• Strong Understanding of Validation Procedures & Statistical Analysis
• Project Management experience
• Demonstrated problem solving skills
• Technical proficiency in statistical tools like Minitab
• Application of GD&T
• Business/financial competence
• Able to work in a team based, collaborative environment

• Strong knowledge of process validations
• Experience with supplier selection and qualifications
• Technical proficiency in CAD tools like Solid Works and/or AutoCAD
• Six sigma and process excellence…