1+ months

Contract Manufacturing Engineer II

Kelly Services
St Louis, MO 63112
**Contract Manufacturing Engineer II**

**Job Description**

This position provides manufacturing engineering support to a medical device and disposables manufacturing operation. Reporting to the Manufacturing Engineering manager, this individual actively participates on cross-functional teams within R&D and Manufacturing/Operations to develop designs and processes for ophthalmic surgical equipment, including both current product support and new product development. Responsibilities include coordination and execution of product transfer from R+D to manufacturing, as well as development and refinement of processes for current commercialized medical products to ensure production continuity, improve yield, and reduce overall product costs. Direct responsibilities include, but are not limited to, designing/implementing new manufacturing processes and tooling, improving existing product designs and manufacturing processes, and providing technical guidance to manufacturing personnel.

**Job duties**

+ Suggest and aid in product redesigns to mitigate changes in raw component characteristics or availability on existing commercialized products.

+ Improve production processes, equipment, and methods to reduce cost and cycle time.

+ Assist in generating CAD documentation, author SOPs and test instructions, and create/update PFMEAs while ensuring that necessary verification and validation activities are performed according to Quality Systems Regulations.

+ Correct and resolve manufacturing issues to minimize production downtime.

+ Work on new product and process design teams, as well as act as a lead on change coordination that may impact assembly operations and test processes.

+ Independently lead manufacturing projects and change implementation initiatives.

+ Lead and assist with CAPA investigation, root cause analysis, and deviations, both independently and within a team environment.



+ Education: Bachelors Degree in an Engineering discipline or equivalent experience.

+ Five (5) years of professional related experience, with three (3+) years providing manufacturing support in a regulated industry.

+ Ability to operate successfully within the constraints of a GMP environment, including strict adherence to Quality Management System documentation requirements.

+ Proficiency in MS Office suite (Word, Excel, MS Project).

+ Ability to collaborate with cross-functional associates and prioritize projects to meet deadlines, possessing and exhibiting strong time and resource management skills.

+ General knowledge of medical, engineering, and biomedical product development.

+ Exceptional interpersonal and communication skills.

+ ?Ability to work independently, effectively, and confidently in a team environment.

+ Ability to analyze data and propose solutions.


+ Education: Bachelor's Degree in Mechanical, Electrical, Industrial, or Biomedical Engineering preferred.

+ Three to five (3 to 5+) years in medical device or disposables manufacturing preferred.

+ Proficiency in SolidWorks strongly preferred.

+ Proficiency in MS Access preferred.

+ LEAN or Six Sigma training and/or certification preferred.

**Why Kelly** **** **?**

Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-11-05 Expires: 2022-01-06

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Contract Manufacturing Engineer II

Kelly Services
St Louis, MO 63112

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