Medical Device Engineer

Only US Citizen, Green card holder , GC EAD (No VISA transfer)

Engineer - Medical Device Engineering

Location: Thousand Oaks, CA

Duration: 12 months (Possible extension)

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.

Job Type: Contract

Pay: $30.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work setting:

• Remote

Education:

• Bachelor's (Required)

Experience:

• Production, Sustaining Engineering, or Quality roles: 2 years (Preferred)
• Medical Device,Combination Products Design: 2 years (Preferred)

Ability to Relocate:

• Thousand Oaks, CA: Relocate before starting work (Required)

Work Location: In person