Engineering Test Lab Manager

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.

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:

The Test Lab Manager is responsible for operational oversight of the mechanical testing lab activities. These activities include:

• Managing a medical device mechanical testing laboratory
• Planning, execution, and documentation of mechanical (static, dynamic) testing
• Performing and/or scheduling equipment maintenance and repair.
• Supporting regulatory requirements
• Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.

The employee 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 Adva Med 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 and Skills:

• Direct daily mechanical testing lab functions including test execution and reporting.
• Collaborate with individual test requestors and project management on test scheduling across multiple projects.
• Manage equipment including calibration, maintenance and overall resourcing.
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO
  14971), 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 Lab Manager 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 Adva Med 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.
• Support the SI-BONE Quality System

Knowledge,

Education…