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General Responsibilities:
· Mechanical engineering experience in a medical device environment which includes working with CAD, Solid Works, Pro E, etc. in conjunction with change control processes.
· Perform supplier sourcing, evaluation and management in conjunction with quality management systems in the design for manufacturability.
· Provide strong verbal and written skills in support for creation and development of standard operation procedures, work instructions, inspections documentation, change controls and visual aids as applicable.
· Create and maintain accurate documentation of tool drawings, design concepts and orders, in accordance with the Product Development and Quality Assurance functions.
· Collaborate with peers to design and develop supply chain manufacturing processes for new products, enhancements, product changes, and related fixtures and tooling that are consistent with zero defect level.
· Support Engineering Change Notice (ECN) and related Material Review Board (MRB) activities including disposition and root cause investigation of non-conforming materials.
· Participate through the project validation phases with transition to manufacturing operations which includes efficiency gains/improvements post pre-product status (includes tooling, fixtures, processes and costs).
· Participate in cross-functional teams with a focus on product packaging technologies, testing, validations and labeling (including IFUs – Instructions for Use) with Bar Coding and use of GTINs (Global Trade Identification Numbers).
· Assist in the evaluation of returned materials/products.
· Support and adhere to company policies, procedures, goals and objectives, QSR/FDA regulations and evaluate suppliers for good manufacturing practices.
· This position requires travel to supplier facilities to observe and evaluate supplier manufacturing and assembly processes.
· Perform other duties that may be assigned as necessary.
· Support the SI-BONE Quality System.
Qualifications and Attributes:
- Bachelor’s Degree in Manufacturing Engineering or Mechanical Engineering.
- Minimum of 4 years’ manufacturing engineering experience, with specific experience in medical devices/components
- Strong knowledge of manufacturing technologies for Class I and II medical devices, specifically in the orthopedic and implantable space is highly preferred.
- Experience in multiple roles and responsibilities conducive of a company in a current state of product development and maturation.
- NPI and product launch exposure
- Experience drafting manufacturing change documents
- Computer skills: Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems (QAD).
- Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer
- Experienced in designing, analyzing, acquiring and qualifying manufacturing tools and equipment.
- Familiar with statistical tools and concepts such as ANOVA and DOE methods.
- Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
- Excellent time management skills, take initiative to meet deadlines and the ability to prioritize workload and minimal supervision.
- The ability to network and interact effectively with a broad range of associates spanning varied disciplines and responsibilities.
- Must have a strong passion for product and process excellence and customer satisfaction.
Salary range: $114,000 - $130,000. 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
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