Sr. Manufacturing Engineer - Shockwave Medical

Position Overview Senior Manufacturing Engineer – Shockwave Medical (Santa Clara, CA) is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Senior Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines. 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. Essential Job Functions Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures. Support and work with Quality to address and resolve non-conformances. Collect data and analyze process performance and capabilities for company products, including new products and products already in production. Identify process requirements, advise and support operations management, and implement equipment and fixtures needed for process development and manufacturing efforts. Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills‑of‑materials, MPI’s, LHR’s), and other Quality System requirements. Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians). Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity. Assist Procurement and R&D departments with supplier selection and technical development. Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products). Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel. Requirements Bachelor’s degree in Engineering. Minimum five (5) years of experience in a medical device environment or 3 years of experience with a master's degree. Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements) Experience implementing Lean and Lean Sigma concepts. Experience with validation of medical devices (IQ‑OQ‑PQ). Proficiency in statistics (Cpk, hypothesis testing, DOE, Gage R&R) a plus. Ability to use special software such as Solidworks, Minitab or 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. May be required to occasionally lift objects up to 25lbs. Additional Information (Benefits) Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time – 40 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year An internal pre‑identified candidate for consideration has been identified. However, all applications will be considered. For additional general information on Company benefits, please go to: Required Skills Accelerating Analytical Reasoning Coaching Communication Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Manufacturing Science and Technology (MSAT) Problem Management Project Engineering Project Schedule Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy Preferred Skills Accelerating Analytical Reasoning Coaching Communication Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Manufacturing Science and Technology (MSAT) Problem Management Project Engineering Project Schedule Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy Compensation Base pay range: $91,000.00 - $147,200.00 #J-18808-Ljbffr Johnson & Johnson