Senior Verification and Validation Engineer

About This Role

Lead verification and validation testing for new product development, ensuring products meet regulatory requirements and quality standards for a medical device company focused on sacroiliac joint solutions.

Responsibilities

• Conduct design verification and validation testing for product development activities
• Support all technical aspects of the product and instruments
• Support regulatory requirements and the design control process
• Support sustaining engineering activities with root cause and engineering analysis
• Lead the engineering change process
• Write protocols, assessments, conduct testing, and write test reports (e.g., performance, simulated use)
• Source appropriate vendors to conduct testing and oversee their testing
• Support the SI-BONE Quality System

Requirements

• Minimum 3 years as V&V engineer for a high-growth medical device organization
• Exceptional organization/planning skills
• Good technical writing skills with attention to detail
• Experience performing testing to established standards (i.e. ISO, ASTM)
• Strong communication skills and ability to work with co-workers, surgeons, clinicians, and distributor reps
• Working cross-disciplinary understanding of a medical device business (engineering, manufacturing, operations, R&D, product marketing, clinical, regulatory, quality assurance)
• Demonstrated ability to design and fabricate mechanical test fixtures using machining or 3D printing

Qualifications

• BS in an engineering discipline (Mechanical engineering preferred)
• Minimum 3 years as V&V engineer for a high-growth medical device organization

Nice to Have

• Experience in orthopedics
• Spine experience

Skills

* Required skills

Benefits