Manufacturing Engineer

Manufacturing Engineer
Bothell WA
9 months contract to start with

Responsibilities:
 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 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.
 
 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
 • Experience in creation and review of process FMEAs strongly preferred
 • Experience reviewing nonconformance data to assess risk in existing process FMEAs strongly preferred

Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
 510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar 

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