This position plays a key role in supporting the manufacturing of a Class III implantable Neuromodulation system for pain management. This position reports to the Senior Director of Operations.
• Supporting the manufacturing of Class III implantable Neuromodulation system components.
• Defining manufacturing processes and executing manufacturing activities including qualification and validation.
• Write, review and oversee verification and validation activities.
• Resolving technical issues encountered during manufacturing.
• Providing troubleshooting training to contract manufacturing engineers and technicians.
• Driving process improvements affecting yields, capacity increases, cycle time reductions and cost reduction initiatives.
• Oversee technology and process transfers.
• Participate in developing Process and Design FMEAs
• Initiate and review ECOs.
• Interfacing with other departments such as R&D, Regulatory, and Quality.
• Working in accordance with Quality System procedures and actively enforces its objectives.
Skills and Knowledge
- B.S. Mechanical Engineering, or similar degree. Advanced degree (M.S.) is preferred.
- A minimum of 8years of experience within the Medical Device industry, preferably manufacturing and/or designing implantable Leads and Implant Tools.
- Strong electro-mechanical design/manufacturing and analysis skills.
- Experience with Solidworks.
- Good analytical and problem solving skills.
- Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements is also preferred.
- Strong interpersonal and technical writing skills.
- Experience managing contract manufacturers.
- Knowledge and experience using structured project management tools.
- Requires the ability to travel approximately 20% of the time throughout the United States and internationally.