Location
Thousand Oaks, CA | United States
Job description
Engineer - Medical Device Sustaining Engineering
Location: Thousand Oaks, CA
Duration: 12 months (Possible extension)
Description:
Key Responsibilities:
- Execute product and manufacturing process changes, ensuring documentation and risk file updates to maintain product design integrity.
- Implement change projects according to internal procedures, overseeing progress, and communicating status to group leadership.
- Collaborate with Engineering, Manufacturing, Regulatory, and Quality colleagues.
- Establish experimental protocols, conduct experiments, and analyze results.
- Support technical execution of Design History File (DHF) updates.
- Build and maintain relationships with manufacturing site colleagues.
- Assist Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/process changes.
- Establish and review specifications/requirements for components, products, and processes.
- Support CAPA investigations.
- Ensure product conformity to current relevant international standards.
- Support multi-functional assessment of complaint records.
- Complete product and manufacturing process changes, including documentation and risk file updates to maintain product design integrity.
What we expect of you:
Preferred Qualifications:
- Bachelor's degree in Engineering, Science, or other technical degree.
- 1-3 years of experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality roles.
- Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
- Experience analyzing patient/user impact.
- Understanding and practical knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971, and relevant industry standards.
- Critical thinking and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Working knowledge of statistical methods for data analysis.
- Familiarity with microcontroller-based firmware, software verification, circuit design, analysis, troubleshooting, testing, PCB/PCA assembly, and fabrication.
- Ability to communicate technically with various engineering fields.
Top 3 Must-Have Skill Sets:
- Medical device industry experience and regulated work environment experience.
- Medical Device Design Controls experience.
- Root cause analysis experience.
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