Job Title: R&D Engineer
Location: Minnetonka, MN
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.
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