Position Description:
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
- Managing 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
- Oversee complaint investigations & failure analyses
- Problem solving and statistical data analysis
- Risk Management and FMEA documentation
- Design and develop fixturing, 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
Key Competencies
- 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.
Qualifications
- 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
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