Si-Bone-posted 8 months ago
$132,000 - $148,000/Yr
Full-time • Mid Level
Santa Clara, CA
Merchant Wholesalers, Durable Goods

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. The position requires the candidate to be local and onsite 5 days a week. 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.

  • 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 and ISO 14971.
  • 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.
  • Reporting any instances of potential non-compliance with applicable standards or regulations.
  • Performing all duties in compliance with all applicable worldwide regulatory requirements.
  • 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).
  • 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 problem-solving skills and initiative.
  • High integrity, sound character, and a tremendous work ethic.
  • Salary range: $132,000-148,000 (California - SF Bay Area).
  • Supplemental pay: bonus and stock.
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