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.
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 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 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 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.
- Support the SI-BONE Quality System
Knowledge, Education and Experience:- BS in an engineering discipline (Mechanical engineering preferred)
- Equipment Proficiency - 5+ years hands-on experience with mechanical testing equipment (e.g., Instron, MTS). Proficiency designing test fixtures and handling fabrication. Experience performing preventative maintenance and repair.
- Knowledge of Standards - familiarity with testing to established ASTM and ISO standards including static and dynamic testing. Preference for orthopedics and/or spine.
- Data Integrity - meticulous eye for detail and is process oriented with traceable documentation practices to ensure compliance and repeatable results.
- Communication - good communication/writing skills to effectively interact with co-workers. Proficiency with Microsoft Office tools (Outlook, Word, Excel).
- Safety Culture - a commitment to safe equipment usage (e.g., PPE, guarding)
- Mentorship - the ability to work with colleagues to foster technical growth
- A passion for supporting an emerging company and sustaining high growth through engineering support.
- Be a proactive person who attacks problems, displaying initiative and perseverance in order to bring about meaningful change, and to be open and responsive to new ideas.
- Be known as a person who has high integrity, sound character, a tremendous work ethic, and the passion to succeed.
Salary range: $132,000-$148,000. 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 "[redacted]-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.
