Manufacturing Engineer II

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 Manufacturing Engineer will work closely with SI-BONE’s Product Development Team and outsourced manufacturing suppliers to create, improve, implement and document processes and procedures to manufacture, package and label the company’s products.

In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.

The Manufacturing Engineer must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

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.