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27700 SW 95th Ave Wilsonville, OR 97070
Manufacturing responsibility for the operation and control of manufacturing equipment line, including operation, service, debugging system problems and assisting manufacturing personnel.
Performs and participates in process validation and change verification activities, ensuring conformity to ISO and FDA requirements.
Works with Quality Engineering to develop and document manufacturing work instructions, quality reporting system and failure investigation activities.
Coordinates activities associated with " first article build" of new products, packaging and labeling requirements to ensure that fabricated and kitted item are traceable to documented specifications and design requirements at the time of product release.
Performs manufacturing activities
Provides oversight of the manufacturing process, yield reports, loss and change order activity.
Supports prototyping activities of new product development.
Domestic and International travel up to 25% as required.
B.S. in Engineering or equivalent, 3-7 years experience in medical device industry or related field.
Demonstrated experience in manufacturing equipment operation, debugging and designing mechanical assemblies.
Demonstrated ability to diagnose design and process problems with creative and unique solutions
Demonstrated ability to communicate ideas and concepts both efficiently and effectively.
Experience with assembly methods, IQ, OQ, and PQ requirements.
Solid understanding of mechanical measurement tools.
Salary: $85k+ DOE