Engineer

Job Title: Engineer
Duration: 6 months
Location: Bothell WA

This position will be reporting to the team helping to remediate FDA and other Agency Audit findings. The following skills are required for this job: 

Candidate Responsibilities 
• 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 FMECA 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. 

Candidate Profile 
B.S. in an Engineering discipline or Technical field is highly desired. 
• Prefer 3-5 years’ experience 
• Microsoft Office applications, including PowerPoint and Project 
• Basic understanding of software coding in any standard language. 
• Statistics, including SPC and DOE 
• Experience with process and equipment validations 
• Knowledge of GMP ISO-14971, and ISO-13485 
• Experience with FDA-regulated medical device manufacturing helpful

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