Engineering Machine Shop Manager

Must 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 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. 

Responsibilities may include, but are not limited to:   

• Managing a medical device machine shop.
• Machining medical device prototypes using in-house
• Maintaining medical device machining equipment including preventative maintenance and IQ, OQ, PQ when
• 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
• Interaction with the engineers and other groups within SI-
• Participates on the Safety
• The machine shop manager must act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s Code of Conduct, other company policies and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.
• 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 Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality and/or Regulatory and the respective management
• 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:

• Managing and maintaining a medical device machine
• 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.
• Provide Training and Guidance to Operators as
• Support the SI-BONE Quality System
• Currently or recently served as machinist and shop manager for a high-growth organization for a minimum of 5 years.
• Experience in medical devices and orthopedics highly preferred

Expertise:

• Have a track record of producing quality, close-tolerance parts and working with design and manufacturing engineers to develop innovative engineering solutions and cost-effective
• Have demonstrated ability to communicate effectively and work well with a cross-disciplinary team including engineering, manufacturing, quality assurance, operations and R&D.
• 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.
• Knowledge and familiarity of applicable regulations/standards (g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function.

Education and Experience:

• Apprenticeship, certificate and/or BS degree
• 5+ years of medical device machining
• Familiarity with local permitting and zoning

Salary range:  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 considering 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.     

$132,000-148,000 (California – SF Bay Area)  

Supplemental pay:  bonus and stock