Manufacturing Engineer II
About The Position
Johnson & Johnson is hiring for a Manufacturing Engineer II – Shockwave Medical to join our team located in Santa Clara, CA . 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. Position Overview The Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, the Manufacturing Engineer II will sustain activities on the production line such as raw material, process and equipment issues.
Requirements
- Bachelor’s degree in Engineering.
- 3-5 years of experience in a medical device environment.
- Understanding of Lean and Six Sigma concepts.
- Able to create and maintain Drawings in SolidWorks.
- Experience with ERP and MES (Oracle preferred)
- 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 lift objects up to 25lbs or more.
- Employee will be required to work in an air-conditioned Class 8 Cleanroom.
Nice To Haves
- Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R&R) a plus.
Responsibilities
- Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
- Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
- Coordinate and/or perform functional and destructive testing to support Engineering Reports.
- Document the results and provide a statistical analysis using Minitab or excel.
- Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
- Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
- Create, maintain and transfer paper Bill of Materials (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s.
- Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
- Create and release label files used for printing product labels.
- Create and execute process validation protocols and reports.
- Other duties as assigned.
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.
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
