SI-BONE · 1 hour ago
Senior Verification and Validation Engineer
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $150K/yr
3+ years expSI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. They are seeking a Senior Verification and Validation Engineer to conduct design verification and validation testing for product development activities and support regulatory requirements.
Medical Device
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
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
Qualification
Required
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
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
BS in an engineering discipline (Mechanical engineering preferred)
Preferred
Experience in orthopedics is highly desired, spine experience also a plus
Benefits
Bonus
Stock
Company
SI-BONE
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.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Laura Francis
Chief Executive Officer
Scott Yerby
CTO and Sr. VP of Engineering
Recent News
2024-05-04
Simply Wall Street
2024-05-04
2024-04-14
Company data provided by crunchbase