Senior Process Engineer
Form Energy
Senior Pre-Market Quality Engineer
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $96,800 - $145,200 per year
Job Level
Senior
About the role
- Serve as a Quality team member on multiple new product development projects and existing manufacturing lines in the Components Focus Factory (MECC)
- Pre-market quality engineering for the components focus factory: develop, modify, apply and maintain quality standards and protocol
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place
- Collaborate with customer sites (downstream Medtronic facilities)
- Drive nonconformance investigation, ensure bounding and containment of product, and escalate for Corrective and Preventive Action as needed
- Drive preventive quality tools (First Time Quality, Quality First Reviews, Operations Quality Walk Gembas) to reduce product and patient risk
- Manage process risk management records and drive risk mitigations
- Devise and implement methods and procedures for inspecting, testing and evaluating precision and accuracy of products and production equipment
- Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; perform statistical analysis to assess cost and responsibility for nonconforming products/materials
- Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
- Execute day-to-day operations and continuous improvement to reduce overall quality risk
- Report to the Operations Quality Manager at MECC and participate in a culture of collaboration and compliance
Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
- CAPA (Corrective Action / Preventive Action) experience (nice to have)
- Familiarity with Minitab Statistical Software (nice to have)
- Lean Six Sigma training, DRM Training (nice to have)
- Experience working in a fast-paced manufacturing environment (nice to have)
- Validation Experience (IQ, OQ, TMV, PQ) (nice to have)
- Experience with Batteries (nice to have)
- High level of attention to detail and well organized to manage multiple projects at a time
- Ability to be on-site a minimum of 4 days per week
- Regular mobility, computer interaction, and communication with peers and co-workers as physical job requirements
