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Manufacturing EngineerMinneapolis, Minnesota
- Works within an integrated team to provide medical device product and manufacturing subject matter expertise to advance products from concept to production.
- Take ownership for the design and development of process, with emphasis toward designs that enhance or improve and reduce cost
- Assist and lend expertise in problem solving activities on existing production activities.
- Recommends material specifications/standards for use in manufacturing
- Apply Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, and supports the execution of process improvement efforts
- Applies statistical analysis techniques to quantify current process capabilities
- Participate in Design Reviews, DFMEAs, FMEAs and periodic status review meetings on new programs
- Interpret production drawings using GD&T and how to properly apply it to yield the desired fits between joining parts
- Assist investigation of device failures to determine root cause and corrective action
- Assist process development activities, write work instructions, and develop in process inspection procedures
- Candidate must possess a minimum of a Bachelor's or advanced degree in Engineering.
- Thorough knowledge of quality systems, Quality by Design, validation, design transfer, and quality engineering principles for devices and combination products
- Thorough knowledge of industry standards and FDA/EMEA regulatory guidance on combination products and medical devices, specializing in auto injectors
- Strong communication skills both verbal and written