Job Title: Engineer I
Duration: 8+months with possible extension
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:
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 2+ 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
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | firstname.lastname@example.org