Medical Device Process Development Test Engineer

Akkodis is seeking a Medical Device Process Development Test Engineer for a 12-month contract job with a client in Minnetonka, MN. You will support the development, characterization, validation, transfer, and improvement of manufacturing and assembly processes for medical devices and related subsystems. You will perform hands-on technical work, develop and evaluates fixtures and methods, execute engineering studies and validation activities, and partner with R&D, Operations, Quality, and Supply Chain to establish robust and repeatable processes.

Rate Range: $53.33/hour to $57.14/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device Process Development Test Engineer job responsibilities include:

• Build, modify, troubleshoot, and evaluate prototype and production processes, fixtures, tooling, equipment, and assemblies in support of new product development and process transfer.

• Support process development activities including assembly method definition, parameter development, process characterization, capability assessment, and identification of critical process variables.

• Execute engineering studies, design of experiments as directed, equipment qualification, process validation, and production-equivalent builds; collect and document data in a clear and traceable manner.

• Develop, modify, and maintain controlled manufacturing documentation including work instructions, routers, bills of material, process specifications, tooling records, and test methods.

• Identify process risks, failure modes, sources of variation, and opportunities for improved safety, quality, yield, cycle time, cost, and manufacturability; communicate observations and recommended actions to Engineering.

• Design, fabricate, qualify, and maintain production aids, assembly fixtures, test fixtures, and other process-development tooling.

• Support transfer of new or modified processes from R&D into Operations, including operator training, build support, issue resolution, and documentation readiness.

• Operate, troubleshoot, and maintain laboratory and production equipment; help establish equipment maintenance, calibration, and usage practices as appropriate.

• Support investigations of process issues, nonconformances, and build anomalies using structured problem-solving methods and objective data.

• Collaborate closely with R&D, Operations, Quality, Supply Chain, and suppliers to support project schedules and department objectives.

• Follow approved procedures, protocols, good documentation practices, and applicable quality-system requirements while maintaining an organized and compliant work area.

Desired Qualifications:

• Associate degree, technical diploma, or certificate in mechanical, manufacturing, electromechanical, industrial, or a related technical discipline; equivalent practical experience may be considered.

• 3+ years of relevant technician, process-development, manufacturing-engineering, or equivalent hands-on technical experience preferred.

• Experience in medical devices or another regulated industry with exposure to GMP, ISO, FDA, or comparable quality-system requirements is preferred.

• Experience supporting new product introduction, manufacturing transfer, process validation, and/or equipment qualification.

• Experience with fixture fabrication, machining, rapid prototyping, adhesive processes, precision assembly, or other medical-device manufacturing processes.

• Experience with formal problem-solving and statistical methods, including capability studies or measurement-system analysis.

• Strong hands-on mechanical aptitude and comfort working with tools, fixtures, manufacturing equipment, and electromechanical assemblies.

• Demonstrated analytical and problem-solving ability, particularly in process troubleshooting, variation reduction, and continuous improvement.

• Ability to read and interpret engineering drawings, specifications, tolerances, and work instructions; familiarity with GD&T is beneficial.

• Working knowledge of measurement and inspection equipment such as calipers, micrometers, force gauges, torque tools, and other laboratory instruments.

• Strong written and verbal communication skills with the ability to document technical work and communicate issues, results, and recommendations clearly.

• Ability to manage multiple priorities, work independently on assigned tasks, and operate effectively in a fast-paced product-development environment.

• Working knowledge of Microsoft Office applications; experience with statistical analysis tools such as Minitab is a plus.

• Understanding of Lean manufacturing, root-cause analysis, process capability, and validation concepts is a plus.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance