Test Engineer/Senior Test Engineer - SI-BONE, Inc
Santa Clara, CA
About the Job
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.
Test Engineer/Sr. Test Engineer
Regular, Full time, Exempt
Preferred Location: Santa Clara, CA
Travel: Occasional -- 10-20%
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 Test 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 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 and Skills:
- 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, 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 and Attributes:
- Currently or recently served as test 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.
- Currently or recently performed testing to established standards (i.e. ISO, ASTM).
- Exceptional organization/planning skills (e.g., scheduling) and display initiative and perseverance in meeting deadlines.
- Good technical writing skills with attention to detail.
- 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.
Salary range: $114,000 - $145,000. 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
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 www.si-bone.com/risks.
We 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 "@si-bone.com" to communicate with candidates.
If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.