Title: Manufacturing Engineering Manager
Classification: Regular, Exempt, Full-time
Reports to: Director of Operations
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.
Lead a team of Manufacturing Engineers who are working to bring Invuity’s advanced photonics technology to a wide variety of surgical applications through the development of new products as well as continuous improvement of existing processes and products. Serve as a liaison between R&D and production, provide support to in house manufacturing, contract manufacturing and suppliers. Guide and mentor engineers through the development and implementation of new processes as well as improvement of current process that are cost effective, scalable and produce high quality products.
Essential Duties and Responsibilities
This position is responsible for, but not limited to:
Management Duties: Manage the Manufacturing Engineers including developing and mentoring, providing guidance and setting goals and objectives for individuals
Manage team resources to ensure projects are adequately staffed
Prioritize, manage and plan projects of the team and ensure cross functional participation.
Oversee continuous improvement and sustaining Engineering projects
Provide technical support in the selection of suppliers and contract manufacturers
Troubleshooting and data analysis as it relates to complaint investigations, failure analysis, manufacturing process and equipment and design.
Design and develop fixtures, validate processes and equipment in house and at supplier locations
Define manufacturing flows to maximize production efficiency
Proactively identify bottlenecks and provide solutions
Work with Production Manager, Materials and Quality to ensure production schedule and goals are met
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Change Order process
Ability to motivate, mentor, and inspire a high capacity technical team
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
Technical expertise across a variety of manufacturing processes: machining, injection molding, automation, welding
Mechanical design and analysis expertise, including statics, dynamics, kinematics, strength of materials, and stress analysis desired.
B.S. in an Engineering discipline
10+ years in the Medical Device industry
3+ years of management experience
Experience developing products from early stage concept to volume manufacturing
Prior responsibility for validation of processes, equipment and products
Proficient in Solidworks and Minitab (or equivalent statistical software)
Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments is a plus