Careers
Manufacturing Engineer
| Job title: | Manufacturing Engineer |
| Posted on: | 04/26/2012 |
| Status: |
Company Information
| Company: | BARRX Medical |
| Website: | www.barrx.com |
Job Description
Major Duties and Responsibilities:
· Provide engineering support to the manufacturing floor and resolve issues impacting production fulfillment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment).
· Provide primary DFM analysis and guidance to R&D teams.
· Champion’s continuous improvement projects to enhance yield, consistency, performance, capacity, etc. of equipment and processes.
· Define, write, and update process limits, process instructions, BOMs, and LHRs/Work Orders.
· Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield.
· Work with production team to ensure controlled environment room is well maintained, safe, and provides a suitable work environment for assembly operations.
· Provide floor layouts for areas associated with manufacturing operations.
· Work with R&D teams to transfer new products into commercial manufacturing.
· Write test protocols, perform tests to fully characterize new equipment or processes utilizing DOE methodology or other statistically sound methods, then write completion reports.
· Perform process capability assessments and establish methods to control process output.
· Create process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.
· Write and perform IQ’s, OQ’s and PQ’s when introducing new or changing existing manufacturing equipment.
· Provide engineering support to outside suppliers, ensuring quality and production targets are met.
· Train, develop, and/or provide work direction to operators and technicians.
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Education Requirements: |
· BS in Engineering |
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Experience Requirements: |
· Minimum, 3 years of related experience in Medical Device or other regulated healthcare industry. · Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001.
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Other Qualifications:
· Good written and oral English communication skills.
· Excellent organizational skills
· Experience using MS Office Suite Programs, Solid Works, and MS Project.
· Must be able to travel to support outside supplier initiatives (5-10%).
