Medical Device Sustaining Engineer
Job #2444: Chameleon Technologies is searching for a Medical Device Sustaining Engineer for a fulltime position in Seattle. Our client is a leading manufacturer of medical devices for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Their products are used in hospitals, clinics and laboratories worldwide. Their mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
- Medical Device Industry experience handling Class I, II and III devices.
- Familiarity with various regulations and standards- ISO 13485, IEC 60601, 21CFR Part 820 (Design Controls)
- Strong skills and understanding of Design and Process validation, generating pFMEA’s, IQ, OQ, PQ, TMV (Test Method Validation) and process controls
- Manufacturing experience with hands on experience in medical devices and accessories. Drafting ECR’s, ECO’s, DCO’s etc. Apply working knowledge of product design and assembly to the manufacturing process
- Familiarity and knowledge of Solidworks/EPDM to create, modify existing drawings. Analyze mechanical designs. Need Mechanical skills.
- Statistical knowledge and familiarity with data handling especially when the data is skewed and abnormal.
- Experience in dealing with Contract Manufacturers and interactions.
- Produce DHF and DMR documentation for transfer to test/manufacturing.
- Perform all duties in compliance with the quality management system; actively contribute to the continuous improvement of the QMS.