Manufacturing Engineer BARRX Medical
ESSENTIAL 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.
Lead cross-functional manufacturing projects
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%).
BS in Engineering
EXPERIENCE (please note required or Preferred):
Minimum, 3 years of related experience or equivalent 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.
WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:
Usual office environment with frequent- sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional- climbing.
Frequent- use of eye, hand and finger coordination enabling use of office machinery.
Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
Light physical effort required by handling objects up to 20 pounds occasionally- and/or up to 10 pounds frequently.
-Occasional: Activity exists less than 1/3 of the time.
-Frequent: Activity exists between 1/3 and 2/3 of the time.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
||540 Oakmead Parkway |
Sunnyvale, CA 94085