+1 866 906 4197
LOCATION: Wilsonville, Oregon
• 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 document and development manufacturing process flow, assembly methods and IQ, OQ and PQ of production equipment in accordance with ISO 13458 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 items 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.
• Provide support of manufacturing process, yield reports, loss and change order activity.
• Domestic and International travel up to 25% as required
• BS 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 in with assembly methods, IQ, OQ, and PQ requirements.
• Solid understanding of mechanical measurement tools.
How We Take Care of Our Own:
AgaMatrix offers competitive compensation packages including medical, dental, disability and life insurance as well as a company match to our 401k Plan.