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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