Verification and Validation Engineer/Senior V&V Engineer

SI-BONE is a fast-growing publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation evidence education and advocacy.

Verification and Validation Engineer/Senior V&V Engineer

Santa Clara CA (Onsite. Nota remote role)

Salary range: $120000 - $150000

SI-BONE is focused on helping patients in one of the most under-served under-diagnosed and under-treated areas in orthopedics the sacroiliac (SI) joint. SI-BONE developed an innovative patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.

• Creative: We embrace creativity and we need people who are not afraid to challenge the status quo.

• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

General Responsibilities:

• Conduct design verification and validation testing for product development activities
• Support all technical aspects of the product and instruments.
• Support regulatory requirements.
• Support design control process.
• Support sustaining engineering activities with root cause and engineering analysis
• Lead engineering change process.
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs ISO 13485 or ISO14971) the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.
• The V&V Engineer must at all times act and conduct company business in an honest ethical and strictly legal manner complying with the Code of Conduct other company policies the AdvaMed Code and all applicable laws and regulations whether national regional state or local. This individual is encouraged expected and required to report any suspected violations of laws regulations the Code or any other Company policy and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Specific Responsibilities:

• Be the verification and validation lead assisting the product development group in developing SI-BONEs products to ensure constantly improved instrumentation and cutting-edge technology.
• Write protocols assessments conduct testing and write test reports (e.g. performance simulated use).
• As needed source appropriate vendors to conduct testing and oversee their testing
• Support the SI-BONE Quality System.

Expertise:

• Currently or recently served as V&V engineer for a high-growth medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 3 years. Experience in orthopedics is highly desired spine experience also a plus.
• Exceptional organization/planning skills (e.g. scheduling) and display initiative and perseverance in meeting deadlines.
• Good technical writing skills with attention to detail.
• Currently or recently performed testing to established standards (i.e. ISO ASTM).
• Have a demonstrated ability to communicate effectively and work well with co-workers surgeons clinicians and distributor reps.
• Have a working cross-disciplinary understanding of a medical device business emphasized on engineering manufacturing operations R&D product marketing clinical and regulatory and quality assurance.
• Be known as a person who has high integrity sound character a tremendous work ethic and the passion to succeed.
• Currently or recently designed and fabricated mechanical test fixtures to perform mechanical testing using machining (e.g. mill lathe) or 3D printing.
• A passion for supporting an emerging company and sustaining high growth through engineering support.

Educational Requirements:

• BS in an engineering discipline (Mechanical engineering preferred)

Please note that this isnot a remote role. Candidates must reside in the SF Bay Area.

Salary range: $120000 - $150000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions including job-related knowledge; skillset; experience education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits please visit are aware of active recruitment scams using the SI-BONE name in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses which contain @ to communicate with candidates.

If you believe youve been a victim of a phishing scam please visit the Cybersecurity & Infrastructure Security Agency at learn how to report it.