We are looking for a Manufacturing Engineer in 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:
- 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.
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