About the position
Johnson & Johnson is hiring for a Staff Manufacturing Engineer, Shockwave Medical to join our team located in Santa Clara, CA. 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. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Responsibilities
- Work collaboratively 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 in cooperation 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.
Requirements
- Bachelor's degree in Mechanical or Biomedical Engineering.
- Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 6 years of experience 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 of Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing.
- Experience applying statistics and using statistical software, running Capability Studies (Cpk's), 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.
- 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.
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation - up to 120 hours per calendar year.
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
- Holiday pay, including Floating Holidays - up to 13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
