R&D Manufacturing Process Engineer

R&D / Manufacturing Process Engineer - Medical Device Manufacturing

The Resource is hiring for a R&D/Manufacturing Process Engineer for our client, a leading medical device manufacturer in Bloomington, IN.

This is an excellent opportunity for an engineer who wants to build on their experience in manufacturing, process development, and process validation within a medical device environment.

While this position is titled R&D Engineer, the client is specifically seeking someone with hands-on manufacturing/process engineering experience
-someone who has worked directly with production or assembly processes and understands how to develop, optimize, and validate manufacturing processes.

• Location: Bloomington, IN
• Schedule: 1st Shift, Monday-Friday, 8:00 AM-5:00 PM
• Hours: 40 hours/week; no overtime
• Industry: Medical Device Manufacturing

• Support the development and implementation of manufacturing and assembly processes for new and/or modified medical products.
• Assist with setting up and improving production or assembly lines
  .
• Develop, establish, and optimize manufacturing process parameters
  .
• Design and execute process Design of Experiments (DOEs) to evaluate and improve processes.
• Support the transition of processes from development into process validation
  .
• Participate in process validation activities and help ensure manufacturing processes consistently meet established requirements.
• Initiate and support pre-production runs of new products.
• Work closely with Production personnel to identify opportunities for process improvements and implement product or process changes.
• Build, test, and evaluate prototypes or production-related components as needed.
• Assist with technical documentation related to product and process development.
• Support documentation required for FDA and regulatory submissions
  .
• Maintain appropriate engineering and design documentation throughout product development.
• Work collaboratively with Production, Engineering, Quality, vendors, and other cross-functional teams.
• Evaluate raw materials and manufacturing considerations with suppliers and vendors.
• Apply strong analytical and problem-solving skills to troubleshoot manufacturing and process issues.

Candidates will have hands-on manufacturing or process engineering experience
, particularly experience working directly with production or assembly operations.

• Bachelor's degree or higher in Biomedical, Mechanical, Chemical Engineering, Engineering Technology, or a related discipline
  .
• Hands-on experience in manufacturing, production, process engineering, or assembly operations
  .
• Experience developing, establishing, or optimizing manufacturing processes and process parameters
  .
• Experience with process Design of Experiments (DOE).
• Experience progressing from process development into process validation
  .
• Understanding of engineering validation principles and documentation.
• Strong problem-solving and analytical abilities.
• Excellent written and verbal communication skills.
• Ability to work independently while also collaborating effectively with cross-functional teams.
• Ability to work onsite in a fast-paced manufacturing environment.

Medical device experience is not required if you have the right manufacturing/process engineering background.

Candidates with pharmaceutical manufacturing or process engineering experience are encouraged to apply. The client is open to engineers from different industries whose experience transfers well to medical device manufacturing - particularly candidates with experience in:

Candidates must have relevant hands-on, on-the-job engineering experience
, which may include:

• Full-time professional experience

Experience should be directly related to manufacturing, process engineering, production, validation, or medical device/pharmaceutical manufacturing
.