Verification and Validation Engineer/Senior V&V Engineer
Skills
- Experience with verification and validation engineering in medical device industry
- Knowledge of applicable regulatory standards and quality systems (FDA QSRs, ISO 13485, ISO 14971)
- Strong technical writing and communication skills
- Ability to design and fabricate mechanical test fixtures using machining or 3D printing
- Cross-disciplinary understanding of medical device business including engineering, manufacturing, clinical and regulatory areas
- Organizational and planning abilities to meet deadlines
- High integrity and strong work ethic
Responsibilities
- Conduct design verification and validation testing for product development activities
- Support technical aspects of products and instruments including regulatory requirements
- Support design control and sustaining engineering activities with root cause and engineering analysis
- Lead engineering change processes
- Hold authority to halt shipment or processing if standards or regulations are not met, reporting issues accordingly
- Write test protocols, assessments, conduct and oversee testing, and produce reports
- Manage vendor testing relationships as needed
- Support SI-BONE Quality System compliance
Education
- Bachelor’s degree in engineering, preferably Mechanical Engineering
Benefits
- Competitive salary range of $120,000 - $150,000
- Bonus and stock compensation potential
- Opportunity to work onsite alongside a rapidly growing medical device company focused on impactful solutions
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
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