Senior Manufacturing Engineer – Golden Valley, MN
Inspire Medical Systems is looking for an experienced Manufacturing Engineer to support end products built by multiple contract manufacturing facilities. This role will focus on resolving manufacturing issues and improving throughput and yields to maintain product supply to meet demand. Successful candidate will demonstrate knowledge related to working in a regulated industry with ISO13485/GMP experience.
- Provide expert technical support for Manufacturing to meet or exceed goals and objectives.
- Develop and implement process and product improvements. Typically, projects of complex scope and wide magnitude.
- Define and generate all required documentation in support of manufacturing protocols, reports, manufacturing instructions and procedures. These include: Engineering protocols, reports, manufacturing instructions and procedures. Ensure compliance with GMPs and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
- Production Support and Trouble Shooting: Provide engineering support to manufacturing operation. Address related issues arising on the production floor. Lead inter-disciplinary teams to resolve high profile production issues and document recommended corrective actions using the quality systems procedures. (NCMR & CAPA). Ability to lead Failure Investigations.
- Ensures processes and procedures are in compliance with FDA regulations.
- Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Equipment and Fixturing: Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. May collaborate on design with suppliers to fulfill equipment and fixturing requirements.
- Support the transfer of new products and processes from process development to operations. Serve as the technical manufacturing expert to provide feedback during the development cycle and represent operations with the introduction into manufacturing, initial ramp, and stabilization of processes.
- Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Design arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.)
- M.S. degree in an Engineering discipline
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
- 7-10 years increasingly complex engineering responsibilities in a manufacturing environment
- 7-10 years experience in an ISO13485/GMP environment
- Engineering experience with implantable medical devices