Medical Device Manufacturing Engineer

Seattle, WA

Industry: Medical Device Job Number: 133526

Medical Device Manufacturing Engineer 

Environment: 
Our client is a large medical device manufacturer of class II and III products. This individual will be  helping to remediate FDA and other Agency Audit findings. The following skills are required for this job:

• Responsible for defining and implementing Manufacturing processes for new products and managing the changes for exiting products. 
• Responsible for defining, selecting, and validating Manufacturing equipment. 
• Fundamental understanding of Lean Manufacturing Principals 
• Ability to generate process flow maps and utilize results to improve processes and manufacturing operations. 
• Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturing. 
• Responsible for creating the code for the templates necessary to run the paperless factory. 
• Lead teams in performing and updating Process FMEA risk management. 
• Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities. 
• Ensure that all appropriate documentation, drawings specifications are generates in compliance with Philips procedures and regulatory requirements (US FDA and ISO). 
• Knowledge of IQ, OQ, PQ Validation Strategies. 

Required:
Manufacturing Engineering
Experience with process and equipment validations 
Knowledge of GMP ISO-14971, and ISO-13485 
Experience in creation and review of process FMEAs
Experience reviewing nonconformance data to assess risk in existing process FMEAs strongly preferred

Job Type: Contract 

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