3 days old

Manufacturing/Production Engineer

Kelly Services
St Louis, MO 63112
Kelly Services is currently looking to hire a Manufacturing/Production Engineer to work for one of our top Medical Device clients on-site in St. Louis, MO for a long-term contract position. This is an excellent opportunity to work with a renown company in an exciting industry. There are two roles open for this position; one focused on Manufacturing Processes, the other is focused on MDR Validation. If you have experience with both, please advise which you would be more interested in.

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** **** **Engineering?**

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.

**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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Manufacturing/Production Engineer

Kelly Services
St Louis, MO 63112

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