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Verification Validation Engineer, Medical Device

Verification Validation Engineer, Medical Device

SciProSanta Rosa, CA, US
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Job Description

  • This is not a software role

The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons

Responsibilities

Design Verification & Validation :

  • Plan, execute, and document design verification and validation (V&V) activities to support product development and ensure compliance with internal and regulatory requirements.
  • Technical Support :

  • Provide engineering support for all technical aspects of the product, including instruments and systems throughout the product lifecycle.
  • Regulatory Compliance :

  • Ensure product development and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Support documentation and submission efforts as required.
  • Design Control :

  • Participate in and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.
  • Sustaining Engineering :

  • Assist in post-market product support, including root cause analysis and engineering evaluations to address product issues or improvements.
  • Quality and Compliance Authority :

  • Exercise authority to hold any product or QA / RA documentation from shipment or further processing in the event of potential non-compliance. Escalate concerns to direct supervisor or higher management promptly.
  • Qualifications :

    3+ years of recent experience as a Verification & Validation Engineer in a fast-growing medical device company, ideally focused on specialty medical practices.

    Project Management Skills : Strong planning and organizational skills, with the ability to manage schedules and meet deadlines. Shows initiative and persistence in driving tasks to completion.

    Technical Writing : Clear and accurate technical writing skills, with close attention to detail.

    Standards-Based Testing : Experience performing testing in accordance with industry standards such as ISO or ASTM.

    Communication & Teamwork : Strong communicator who works well with engineers, surgeons, clinicians, and sales / distribution teams.

    Cross-Functional Knowledge : Solid understanding of how different areas of a medical device company work together — including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.

    Test Fixture Design : Experience designing and building mechanical test fixtures using tools like mills, lathes, or 3D printers.

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    Validation Engineer • Santa Rosa, CA, US

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