Engineering Program Manager - Santa Ana, CA
$142,400–$213,600 year
On-site · Santa Ana, California, United States
Job Summary
Engineering Program Manager to lead quality-centric programs in medical device development. You will drive program execution from design to market release, represent quality across cross-functional teams, manage risk and documentation, and develop/maintain QA and reliability systems and standards related to materials and manufacturing. Expertise in dFMEA/pFMEA, V&V strategy, CAPAs, and V&V activities, with strong leadership, communication, and the ability to influence diverse teams. Familiarity with QSR, ISO 13485, GMP, and Lean/Six Sigma practices is required. Strong technical background in Electrical, Computer/Software, or Biomedical Engineering with demonstrated program management experience; PMP preferred.
Required Qualifications
- Bachelor's degree in Electrical, Computer/Software, Biomedical Engineering or related field
- Experience in medical device product development or manufacturing
- Experience in Design Assurance or Quality roles
- Strong leadership and communication skills
- Knowledge of Quality System Regulations (QSR), ISO 13485 and GMP
- Proven ability to balance risk and lead cross-functional teams
- Experience with dFMEA, pFMEA, risk analysis
- V&V strategy development
- Lean, Six Sigma, or Design for Reliability and Manufacturing knowledge
- PMP preferred
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