Manufacturing Engineer - Shockwave

Staff Manufacturing Engineer, Shockwave Medical

Location: Santa Clara, CA

The Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The role works closely with production, quality, and R&D teams to support manufacturing operations and product launch timelines.

• Collaborate with R&D, QA, and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
• Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Prepare user requirements, technical specifications, and design specifications.
• Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, and other Quality System requirements.
• Evaluate existing engineering processes and implement process improvements.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participate in process/product improvement projects with production, R&D engineers and technicians.
• Assist Procurement and R&D departments with supplier selection and technical development.
• Recommend new technologies to improve system performance and reliability. Perform productivity and costing analyses, providing solutions that improve efficiency and scalability.
• Identify opportunities and implement cost reduction plans for existing products.
• Support the transfer of product lines and the qualification-validation efforts.
• Other duties as assigned.

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum of eight years experience in a medical device environment or equivalent in pharmaceutical/automotive industries, or six years with a Master’s Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing.
• Experience applying statistics and using statistical software, running Capability Studies (Ckps), and planning and analyzing DOE’s.
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
• Ability to use special software such as Solidworks, Minitab or closely related tools.
• Ability to work in a fast‑paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to occasionally lift objects up to 25 lbs.

Base pay range: $105,000 to $169,050 annually.

Eligible for performance bonus, medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Retirement plan (401(k)) and other benefits may be provided.

Time off benefits include vacation, sick time, holiday pay, floating holidays, and personal/family time.

Johnson & Johnson is an affirmative action and 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, or protected veteran status and will not be discriminated against on the basis of disability.