Manufacturing Process Engineer

Duration: 12 months with potential to extend
Location: Bothell, WA


In this Position, you will be responsible for managing the manufacturing of Clients AED products. Within this role you will have end-to-end responsibility for a production line, which included part delivery, manufacturing and test flows and packaging. You will implement and validate the changes required to meet maintain compliance with Internal documents and regulated industry requirements. 
Candidate Responsibilities 
• Responsible for creating the code for the templates necessary to run the paperless factory.  
• 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. 

• 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 is highly desirable. 
•  
Candidate Profile 
B.S. in an Engineering discipline or Technical field is highly desired. 
• Prefer 1-3 years’ experience 
• Basic understanding of software coding in any standard language. 
• Microsoft Office applications, including PowerPoint and Project 
• Statistics, including SPC and DOE is highly desirable 
• Experience with process and equipment validations is highly desirable 
• Knowledge of GMP ISO-14971, and ISO-13485 is highly desirable 
• Experience with FDA-regulated medical device manufacturing helpful 
• Good technical writing ability

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