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Senior Manufacturing Engineer-Medical Device at GPAC

Senior Manufacturing Engineer-Medical Device

GPAC Newton, MA Full-Time
$90,000 - $120,000/Year
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Sr. Manufacturing Engineer

The Senior Manufacturing Engineer will be responsible for technical and Operations support to a team of Group Leaders, Assemblers, Engineers, and Technicians in a controlled manufacturing environment. Efforts will focus on designing and developing equipment, tooling, and fixtures required for new products.

A qualified candidate will have 7-10 years’ Engineering experience with:


  • Providing training, direction, and manufacturing support for a team of Manufacturing Assemblers and Engineers and Technicians
  • Working with Manufacturing Manager to assure the team’s efforts are in full compliance with quality policies, ISO, SOP’s and manufacturing procedures
  • Understanding and interpreting engineering and production drawings and procedures
  • Training assemblers to production drawings and procedures
  • Assembling components into complex sub-assemblies
  • Performing intermediate assembly tasks such as trimming, polishing, sanding, cleaning, bonding, curing, etc.
  • Packaging products in preparation for sterilization processing
  • Working directly with Manufacturing Manager and Associate Engineer to collect and analyze relevant process data
  • Working with R&D Engineers to support, ensuring manufacturability and a smooth transition from R&D into Manufacturing of new product initiatives
  • Preparing documentation including NCMR’s, ECN’s, and Manufacturing Waivers in support of assembly, packaging, and sterilization operations
  • Providing leadership and support for manufacturing, sales, and quality with regard to complaint resolution, product testing, CAPA investigations and product documentation reviews
  •  Setting up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly
  • Formulating tests, calibrations, and procedures to maintain precision accuracy of devices

Required Skills/Education & Abilities:


  • Bachelor’s Degree in an Engineering. **Significant applicable experience may be considered in lieu of degree
  • 7 years’ engineering experience in a regulated medical device manufacturing environment
  • Solid knowledge of QSR, ISO 13485, and the MDD**
  • Familiarity of LEAN principles
  • Must have ability to read and understand SOP’s, engineering drawings, and manufacturing procedures
  • Basic machine shop skills
  • Ability to collect, collate, and present data effectively

 



***For more information on this opportunity or any others, contact Lindsey Croner directly at 
605.231.4435
**



Resumes may be confidentially emailed to  

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

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Salary Details

This salary was provided in the Job Posting.
$90,000-$120,000
Yearly Salary

Job Snapshot

Employee Type

Full-Time

Location

Newton

Job Type

Manufacturing

Experience

Not Specified

Date Posted

11/09/2022
Apply to this job.
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