Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201046
Primary Function of Position:
Lead a team of Sustaining Manufacturing Engineers pushing the frontiers of minimally invasive robotically assisted surgery by advancing new Endoscope Instruments from concept to production. Refine the current product architecture for optimal reliability, quality and cost. This management role will guide and mentor the Sustaining Manufacturing Engineering organization responsible for developing manufacturing processes and creating all associated manufacturing documentation.
- Lead a team of Sustaining Manufacturing Engineers, in collaboration with other organizations, to advance products either from concept to production or improve while in production, with responsibilities including but not limited to:
- Establish group and individual objectives, priorities, and metrics to:
- Ensure fulfillment of product development goals
- Ensure the professional development of individual team members
- Ensure schedule is achieved
- Ensure quality requirements are fulfilled and maintained
- Employ Design for Manufacturing/Assembly (DFx) to develop optimal product architecture in terms of reliability, quality, and cost.
- Specify, design, document, and build or procure the equipment necessary to perform each process step, while providing necessary manufacturing capacity
- Define ideal manufacturing process flows to maximize production efficiency.
- Author process FMEA’s to identify and address potential manufacturing defects and safety and quality risk
- Validate manufacturing equipment and processes to ensure efficacy and compliance with applicable requirements
- Maintain and improve production
- Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
- Provide technical support for failure analysis and root cause investigation of product failures
- Plan, budget and staff projects, tracking performance throughout
- Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary
- Work with Quality group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures
- Improve product quality and reduce cost
- Improve the manufacturing process as needed
- Mentor and train new employees
- B.S. degree in engineering discipline, M.S. preferred.
- 5-7 years successfully managing a team of Manufacturing Engineers and Technicians
- Successful experience leading projects
- Minimum of five years’ engineering experience manufacturing complex electro-mechanical products.
- Ability to motivate, mentor, and inspire a high capacity technical team.
- Experience developing products from early stage concept to volume manufacturing.
- Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, optics and fiber optics.
- Prior responsibility for validation of processes, equipment and products.
- Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
- Familiarity with mechanical CAD software (Solidworks) and Agile
- 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.
- Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments is a plus
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred