Medical Device Engineer

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:

1. Medical device industry experience and regulated work environment experience.
2. Medical Device Design Controls experience.
3. Root cause analysis experience.