Engineer

• Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices
• Conduct ethylene oxide and radiation sterilization validations, qualification, requalification, routine process monitoring, and technical reviews
• Provide subject-matter expertise for controlled environments and contamination control
• Support cleanroom qualification, environmental and utility monitoring, product bioburden, bacterial endotoxin, particulate, sterility, and ethylene oxide residual testing
• Initiate, support, and technically review Microbiology Investigation Reports, nonconformance reports, issue triage records, and CAPAs
• Apply risk-based problem solving to determine causes, assess product impact, define containment and corrective actions, and verify effectiveness
• Analyze and trend microbiology and sterilization data
• Prepare periodic reviews, quality metrics, and Tier or management-review content
• Identify emerging adverse patterns and recommend escalation or improvement actions
• Assess changes to products, materials, suppliers, manufacturing processes, packaging, facilities, utilities, equipment, and controlled environments for sterility-assurance impact
• Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications
• Partner with Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams
• Resolve quality events, support production and product release decisions, execute new-product or transfer activities, and deliver cross-site compliance initiatives
• Support internal and external audits, regulatory inspections, and formal responses
• Maintain inspection readiness and drive standardization and continuous improvement across regional Microbiology and Sterility Assurance processes

Senior Microbiologist – Sterilization Engineer

• Coordinate the design, installation and start-up of process control, network, electrical, plant construction and process equipment projects
• Support Feed Manufacturing Operations and other business units across several manufacturing plants
• Develop project scopes and drive process improvements with the Region Director of Manufacturing, International Business Teams and Plant Managers
• Perform project and process design
• Prepare capital and expense estimates
• Select contractors
• Specify and purchase equipment
• Develop implementation timelines and coordinate implementation plans
• Recommend methods and standard operating practices for safe and effective control, process optimization and meeting product specifications
• Focus on PLC equipment and processes
• Collaborate with plant operators on the processing floor
• Commission, install and implement projects, including installations of up to three weeks
• Provide training and refine operations improvements across all shifts

Senior Controls Engineer

• Lead advanced test equipment engineering projects from concept through completion
• Ensure alignment with business goals and technical requirements
• Collaborate with cross-functional teams including design, manufacturing, and quality
• Drive project success and innovation
• Manage project schedules, budgets, and resources to meet or exceed project deliverables
• Report directly to the Factory Test Equipment Engineering Manager
• Recruit talent, identify and develop successors, drive retention and engagement, and foster an inclusive culture

Senior Project Engineer

• Lead and execute microbiology and sterility assurance activities for terminally sterilized medical devices
• Perform ethylene oxide and radiation sterilization validations, qualification and requalification, routine process monitoring, and technical reviews
• Provide subject-matter expertise for controlled environments and contamination control
• Support cleanroom qualification, environmental and utility monitoring, product bioburden, bacterial endotoxin, particulate, sterility, and ethylene oxide residual testing
• Initiate, support, and technically review Microbiology Investigation Reports, nonconformance reports, issue triage records, and CAPAs
• Apply risk-based problem solving to determine causes, assess product impact, define containment and corrective actions, and verify effectiveness
• Analyze and trend microbiology and sterilization data; prepare periodic reviews, quality metrics, and Tier or management-review content
• Assess product, material, supplier, manufacturing, packaging, facility, utility, equipment, and controlled-environment changes for sterility-assurance impact
• Develop, revise, and maintain protocols, reports, risk assessments, procedures, work instructions, and technical justifications
• Partner with Quality, Operations, Manufacturing Engineering, Facilities, laboratories, suppliers, contract sterilizers, and product-development teams
• Support quality-event resolution, production and product-release decisions, new-product or transfer activities, audits, regulatory inspections, and compliance initiatives
• Maintain inspection readiness and drive standardization and continuous improvement across regional Microbiology and Sterility Assurance processes

• Develop, review, and support control system designs, electrical interfaces, and automation solutions
• Support equipment design, system integration, testing, troubleshooting, and performance improvements
• Collaborate with multidisciplinary engineering, manufacturing, and project teams
• Review technical drawings, specifications, calculations, and engineering documentation
• Ensure designs meet applicable industry standards, safety requirements, and project specifications

Controls Engineer

• Lead hands-on catheter prototype development from concept through evaluation
• Translate customer needs, user requirements, and project objectives into measurable engineering requirements and prototype objectives
• Generate, model, and evaluate catheter concepts at component, subassembly, and full-device levels
• Create and maintain 3D CAD models, 2D engineering drawings, specifications, and prototype build documentation
• Select and evaluate materials, components, joining methods, and manufacturing approaches
• Build or modify prototypes using catheter-development techniques, tools, fixtures, and laboratory equipment
• Develop and execute prototype test methods and bench setups
• Analyze prototype and test data to identify failure modes and drive design decisions
• Support design verification and risk-management activities, including verification plans, test protocols and reports, design-risk identification, and critical-to-quality characteristics
• Plan and coordinate technical execution of development programs, including plans, schedules, budgets, prototype builds, and deliverables
• Collaborate with customers, technicians, suppliers, manufacturing partners, and cross-functional engineering teams to resolve technical and prototype-build challenges
• Facilitate decisions regarding concept selection, prototype approaches, suppliers, and critical design characteristics
• Communicate technical results, risks, and recommendations
• Provide technical leadership and mentorship to less-experienced engineers

Product Development Engineer III – Catheter Prototyping

• Support execution of early development and clinical manufacturing builds
• Develop manufacturing procedures and work instructions for manufacturing equipment and processes
• Support plant layout, 5S, visual management, and workflow improvements
• Collect and analyze manufacturing data to support engineering decisions
• Partner with operators, technicians, and engineers to troubleshoot issues and improve quality, yield, and efficiency
• Support implementation of new equipment, processes, and manufacturing controls while maintaining a safe work environment
• Participate in pilot operations and R&D team meetings and activities
• Respond to changing priorities in a timely manner
• Perform other duties as assigned

R&D Pilot Manufacturing Engineer – Co-Op

• Optimize processes, layouts, and staffing to improve scalability, quality, and cost efficiency
• Support optimization of process flows, line layouts, staffing, and workstation design
• Participate in process improvements for new and existing products using LEAN and Six Sigma methodologies
• Support cost/benefit analysis for process and equipment changes
• Review and support the Medevio CAPTURE program to evaluate, prioritize, and implement continuous improvement opportunities
• Participate in operations and continuous improvement team meetings and activities
• Respond to changing priorities in a timely manner
• Perform other duties as assigned

Continuous Improvement Engineer – Co-Op

• Lead process design, development, and validation activities for medical devices through the product development process
• Determine solutions for complex problems, process selection decisions, and technical challenges
• Use Design of Experiments (DOE), pFMEA, DFM, and statistics for data-driven decisions
• Develop, implement, maintain, and document technical processes for new product introduction into manufacturing
• Lead tooling, fixturing, and equipment identification, procurement, and installation
• Drive documentation, qualification, or verification of tooling and equipment
• Create or leverage process validation protocols and engineering studies demonstrating technical rationale
• Mentor other engineers and promote a culture of feedback
• Collaborate with technicians and operators on the production floor to solve technical problems
• Establish regional relationships and collaborate to ensure best practices
• Perform other assigned duties

Process Development Engineer III – Catheters

• Provide general support in developing and qualifying new processes and equipment to enable increased throughput or new products
• Support development of test methods to characterize product performance outputs
• Assist with processes for coil winding, polymer reflow, laser welding, and advanced assembly processes
• Analyze data and write technical documentation to support engineering decisions
• Support continuous improvement efforts to improve yields, throughputs, or cycle times
• Participate in process development team meetings and activities
• Respond to changing priorities in a timely manner
• Perform other duties as assigned

Engineer jobs in Minnesota

Senior Microbiologist – Sterilization Engineer

Senior Controls Engineer

Senior Project Engineer

Senior Microbiologist – Sterilization Engineer

Controls Engineer

Product Development Engineer III – Catheter Prototyping

R&D Pilot Manufacturing Engineer – Co-Op

Continuous Improvement Engineer – Co-Op

Process Development Engineer III – Catheters

Process Development Engineer – Co-Op