Location
Us, 50250 | France
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 NonConforming 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 multifunctional 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:
- Bachelors degree in Engineering Science or other technical degree.
- 13 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 problemsolving skills.
- Ability to work independently and collaboratively in a fastpaced environment.
- Working knowledge of statistical methods for data analysis.
- Familiarity with microcontrollerbased firmware software verification circuit design analysis troubleshooting testing PCB/PCA assembly and fabrication.
- Ability to communicate technically with various engineering fields.
Top 3 MustHave Skill Sets:
- Medical device industry experience and regulated work environment experience.
- Medical Device Design Controls experience.
- Root cause analysis experience.
Job tags
Salary