BÂRRX Medical, Inc.

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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.

 

 

 

Education Requirements: 

·         BS in Engineering

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.

 

 

 

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%).

 

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