AWESOME OPPORTUNITY FOR A SUPPLY CHAIN MANUFACTURING ENGINEER!
Manufacturing Engineer - Supply Chain Engineering
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:
location: Bothell, Washington
job type: Contract
salary: $55 - 65 per hour
work hours: 8 to 5
- 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.
B.S. in an Engineering discipline or Technical field is highly desired.
- Prefer 3-5 years' experience
skills: - 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
- Experience in creation and review of process FMEAs strongly preferred
- Experience reviewing non-conformance data to assess risk in existing process FMEAs strongly preferred
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.