Zivahh LLC

Medical Device Engineer

Zivahh LLC Thousand Oaks, CA
Zivahh LLC

Medical Device Engineer

Zivahh LLC Thousand Oaks, CA
4 months ago
Over 200 applicants

See who Zivahh LLC has hired for this role

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.


    • Preferred Qualifications

    What we expect of you:

    • 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.

    • Seniority level

      Entry level

    • Employment type

      Contract

    • Job function

      Quality Assurance

    • Industries

      Staffing and Recruiting

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