Process Development Engineer
Posted on: November 22, 2021
A Direct Hire Process Development Engineer position in
Bloomington, Indiana is available courtesy of Modis Engineering.
This position offers full benefits (medical, dental, and vision),
generous PTO, matching 401K, and more. The Process Development
Engineer is responsible for the designing and optimizing of
processes required to manufacture new medical devices. Identify and
evaluate innovative processing options based on product attributes
for products, including evaluation based on technical and economic
feasibility. Execute cost-effective systems in order to enhance the
speed and quality of processing, and ensure produced items comply
with government regulations and industry standards. Must be an US
Citizen or current Green Card Holder.
- Collaborate in a team of engineers focused on design,
development, and implementation of new processes (within facilities
and/or with third party suppliers) required for the manufacture of
new device designs
- Execute methods needed for efficient and effective process
development (design for manufacturing, process validation, process
capability, lean manufacturing, equipment selection and
- Ensure that a risk based approach is applied during the
development implementation and validation of all processes
- Ensuring that the principles of Design for Manufacture, and
Lean manufacturing are central to the R&D process and
- Liaise with production engineering for process engineering
layout plans and implementation in relation to new processes and
- Responsible for process documentation (PFMEA's, Production
Instructions, Drawings etc.) associated with new products
- Collaborate with other R&D teams, Operations, and
Production engineering to ensure the effective completion of all
activities associated with an R&D Engineering project /
- Compare costs and benefits when choosing product in-house or
- Design and optimize process and process equipment for large and
small scale manufacturing
- Ability to complete projects within specific time lines and
meeting performance expectations
- Adhere to the Quality Management System and its processes to
meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory
- Bachelor's or 5 years experience with Master's or 3 years with
- Strong knowledge of process validation, design for
manufacturing, statistics and lean manufacturing principles
- Strong knowledge of medical device quality standards
ISO13485/FDA practices, GMP and similar regulated industry
- Proficient in Microsoft Word/Excel/Outlook
- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for
working with computers, equipment, etc.
- Frequently required to stand, walk, and communicate.
- Must be able to perform the essential functions of the job,
subject to reasonable accommodation requirements under the ADA.
**Qualified candidates must be legally authorized to be employed in
the United States. This position does not intend to provide
sponsorship for employment visa status (e.g., H-1B or TN status) of
this employment position.**
If you are interested in this Process Development Engineer in
Bloomington, IN then please click APPLY NOW. If you have questions
about the position, please contact Erica Goben at .
Keywords: Modis, Bloomington , Process Development Engineer, Engineering , Bloomington, Indiana
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