Manufacturing Engineer

  • location: Bothell, WA
  • type: Contract
  • salary: $40 - $45 per hour

job description

Manufacturing Engineer

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:

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 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.

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

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