Manufacturing Engineer 2

 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