Manufacturing Engineer
18000 Devonshire Street Sherwood Forest, CA 91325 US
Job Description
HM's Top Needs:
- Investigation and root cause analysis skills
- Technical writing knowledge. Organization and Communication skills
- Process Validation and Computer software validation knowledge
Education Required: Engineering degree
Years’ Experience Required: 1-5 years
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Prepare calibration procedures/job plans and associated training materials
- The candidate will also apply statistical process control, mathematical, physical science and advanced engineering tools and technologies to accomplish various metrology engineering objectives
- Working with Calibration Software
- Understanding of measurement traceability
- Equipment Out-of-Tolerance (OOT) / Non-Conformance (NC) investigations experience
- Specific experience with multiple measurement disciplines in areas such as flow, temperature, pressure, electrical, and mechanical
- The engineer will work under the direction of Medtronic’s Engineering team leader and senior Metrology team
- Provide concise analysis reports with context and suggestions for future action items
- Works with teams for new instrument set up, installation, performance evaluation/troubleshooting and qualification/validation
- Understanding of GMP regulations and Good Document Practices
- Ability to interact with various departments/teams
Must Have: Minimum Requirements
- Bachelor’s degree required
- Minimum of 1 year of relevant experience
Nice to Have
- Calibration / Metrology Experience in Medical or Pharmaceutical Industry Environment
- Strong knowledge of calibration related regulatory requirements
- CAPA/NC Experience (preferable as Owner)
- CMMS Experience (preferable with SAP and MAXIMO)
- Good Technical Writing skills
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