About the position
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 looking for people who are passionate about our mission and who are willing to work hard to achieve it.
Responsibilities
- Managing a medical device machine shop.
- Machining medical device prototypes using in-house equipment.
- Maintaining medical device machining equipment including preventative maintenance and IQ, OQ, PQ.
- Maintaining the supply of materials such as bar stock and consumables such as tooling, machining fluids, inert gas, and blast media.
- Establishing and maintaining compliance with standards such as ISO 13485.
- Interacting with engineers and other groups within SI-BONE.
- Participating on the Safety Committee.
- Acting and conducting company business in an honest, ethical and lawful manner.
- Holding any product or Quality documentation from shipment or further processing in case of potential non-compliance.
- Reporting any instances of non-compliance to Quality and/or Regulatory and management.
Requirements
- Experience managing and maintaining a medical device machine shop.
- Experience with mill-turn (e.g., Mazak Integrex), Swiss lathes, 5-axis CNC, and wire EDM.
- Experience with computer aided manufacturing (CAM) software, such as ESPRIT and Autodesk Fusion 360.
- Experience with planning manufacturing schedules and creating / maintaining a traveler system.
- Experience with general shop equipment, such as manual mills and lathes, laser and TIG welding, laser marking, anodization, passivation, and blasting.
- Currently or recently served as machinist and shop manager for a high-growth organization for a minimum of 5 years.
- Knowledge and familiarity of applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971).
Nice-to-haves
- Experience in medical devices and orthopedics highly preferred.
- A track record of producing quality, close-tolerance parts.
- Demonstrated ability to communicate effectively and work well with a cross-disciplinary team.
- Proactive person who attacks problems, displaying initiative and perseverance.
- High integrity, sound character, a tremendous work ethic and the passion to succeed.
Benefits
- Salary range: $132,000-148,000 (California – SF Bay Area).
- Supplemental pay: bonus and stock.
