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.
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.
Numbers & Facts
Location
Minnetonka, MN
Skills
Biomedical Engineeringunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Develop Methodologiesunmatched
Equipment Specificationunmatched
Experiment Designunmatched
Identify Issuesunmatched
Industrial Engineeringunmatched
Machine Toolunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Process Analysisunmatched
Process Developmentunmatched
Process Engineeringunmatched
Process Improvementunmatched
Process Validationunmatched
Product Testingunmatched
Quality Managementunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Safety Processunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Technical Trainingunmatched
Technical Writingunmatched
Test Dataunmatched
Test Plan/Scheduleunmatched
United States Department of Energy (DOE)unmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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