Process Development Engineer

Job Title: R&D Engineer



Location: Minnetonka, MN

Job Responsibilities:

• Develop, author, and execute process validation protocols, including TMV, IMV, IQ, OQ, PQ, and PPQ.
• Support R&D and process development activities, including equipment specification, acquisition, implementation, and improvement.
• Apply engineering principles and techniques to develop, test, and improve products, processes, and equipment.
• Analyze engineering and process problems and develop effective solutions.
• Plan and execute Design of Experiments (DOE), validation testing, and data analysis.
• Evaluate equipment for process suitability and develop improvement plans.
• Develop and revise SOPs, work instructions, specifications, validation protocols, risk assessments, safety procedures, and other technical documentation.
• Support new methods, materials, tooling, equipment, and processes to improve quality and efficiency.
• Collaborate with engineers, technicians, equipment teams, and cross-functional stakeholders on product and process improvements.
• Provide technical expertise and training related to R&D, process development, tooling development, and validation.
• Support continuous improvement, safety, quality, and regulatory compliance activities.
• Present testing, validation, and process improvement results to equipment and cross-functional teams.
• Interact with internal and external customers as required.

Experience Required:

• 1 3 years of experience in R&D Engineering, Process Development, Process Engineering, or related engineering roles.
• Medical device industry experience required.
• Experience with process validation and qualification activities.
• Experience with TMV, IMV, IQ, OQ, PQ, and PPQ.
• Experience with DOE, testing, data analysis, and process improvement.
• Experience developing SOPs, validation protocols, risk assessments, specifications, and technical documentation.
• Ability to troubleshoot engineering and process issues and develop practical solutions.
• Experience working with cross-functional engineering and manufacturing teams.

Educational Background:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a related engineering discipline preferred.