Title: Staff Manufacturing Engineer
Classification: Regular, Fulltime, Exempt
Reports to: Manager, Manufacturing Engineering
Department: Manufacturing Engineering
Invuity, Inc. is committed to leveraging advanced photonics technology to transform and create a new standard of care for minimal access surgery. The Company’s patented Intelligent Photonics™ devices provide superior visualization of the surgical cavity enabling precision, efficiency, and safety. Clinical applications include breast and thyroid oncology, plastics, spine, orthopedic, cardiothoracic and general surgery among others.
Position Description : This position, reporting to the Manager, Manufacturing Engineering, has responsibilities in the following areas: Process Development, Manufacturing Engineering, Facilities/Industrial Engineering, Equipment Engineering, and Product Packaging. The position will work with both R&D and Production for the development, transfer, maintenance, and improvement of production processes for products in accordance with the company’s Quality Systems and customer contracts. This position has responsibility for improving process control, product quality and production costs.
Essential Duties and Responsibilities:
Manufacturing/Process Engineering: Support efforts for developing or improving process capabilities, improving product manufacturability, and reducing scrap and production costs. Design and qualify production fixturing to minimize operator dependence. Create and review process documentation. Interface with Development in the transfer of products and processes. Develop, implement and monitor Statistical Process Control charts.
Design for Manufacturability : In conjunction with Research and Development staff contribute to the design of new products and/ or product enhancements in a cost effective and timely manner and with an understanding of how the product will be manufactured. May be required to lead or contribute to the process of transferring product from development to manufacturing. Device designs are optical, mechanical and electrical.
Training: Train assemblers, technicians or engineers on new processes, documentation, and new product being transferred into manufacturing.
Troubleshooting: The candidate must be able to identify and solve problems using a broad set of skills from measurement analysis to electrical testing and logical exercises.
Compliance : Perform engineering testing and validation. Create associated documentation that is in accordance with regulatory requirements.
Supervision : May be required to supervise, lead or train engineers, technicians and/or assemblers in the project group.
Other duties as assigned.
Broad familiarity with manufacturing technologies required
GMP quality systems environment experience required
Production fixturing design experience with SolidWorks is strongly preferred
Validations experience preferred
Statistics and statistical process control knowledge with Minitab or JMP preferred.
Project Management/Planning experience preferred
Familiarity with both mechanical and electrical product design preferred.
Supervisory or leadership experience preferred
Excellent communications skills (both written and verbal) required
Ability to work independently or in team setting
BS in Engineering or related discipline or equivalent experience; electromechanical experience highly desirable
Minimum 8 years in medical device manufacturing, process development or design
Must be able to travel occasionally