Verification and Validation Engineer/Senior V&V Engineer

Santa Clara, CA (Onsite. Not a remote role)

Salary range: $120,000 - $150,000

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 90,000 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-BONE’s 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 is not a remote role. Candidates must reside in the SF Bay Area.

Salary range: $120,000 - $150,000. 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