Engineering Test Lab Manager
SI-BONE · Santa Clara, CA · 6 days ago
On-siteQuality Assurance$132k–$148k/yrFull-time
About the role
SI-BONE is a fast-growing, publicly traded medical device company pioneering minimally invasive sacropelvic solutions. Its mission is to help patients rise up and reach for the stars, and its 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 focuses on the underserved sacroiliac (SI) joint, having developed the patented iFuse Implant System®, a less invasive alternative to traditional SI joint fusion used in over 90,000 procedures. The company seeks individuals passionate about its mission, willing to work hard, and embodying agility, creativity, and teamwork.
Responsibilities
- 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 and ensuring compliance with worldwide regulatory requirements per the SI-BONE Quality Manual
- Acting honestly, ethically, and legally; reporting suspected violations; no tolerance for retaliation
- Directing daily mechanical testing lab functions including test execution and reporting
- Collaborating with test requestors and project management on test scheduling across multiple projects
- Managing equipment including calibration, maintenance, and overall resourcing
- Having authority to hold product or QA/RA documentation in case of potential non‑compliance with standards (FDA QSRs, ISO 13485, ISO 14971) and reporting such instances to a supervisor
- Supporting the SI‑BONE Quality System
Requirements
- BS in an engineering discipline (Mechanical engineering preferred)
- 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
- Familiarity with testing to established ASTM and ISO standards (static and dynamic)
- Preference for orthopedics and/or spine experience
Skills
- Meticulous eye for detail; process‑oriented with traceable documentation practices
- Good communication and writing skills
- Proficiency with Microsoft Office tools (Outlook, Word, Excel)
- Commitment