LI
Process Development Test Engineer
LanceSoft Inc
🇺🇸 United States
On-site
5 days ago
$50.00 – $53.33 / hour
- calibration
- GD&T
- Microsoft Office Applications
- Minitab
- Lean Manufacturing
- GMP
5 days ago
Location: Minnetonka, MN
Duration: 12 Months
100% Onsite
Duties:
What You Can Expect
- The Process Development Test Engineer supports the development, characterization, validation, transfer, and improvement of manufacturing and assembly processes for medical devices and related subsystems. The role performs hands-on technical work, develops and evaluates fixtures and methods, executes engineering studies and validation activities, and partners with R&D, Operations, Quality, and Supply Chain to establish robust and repeatable processes.
How You'll Create Impact
- 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.
Skills:
What Makes You Stand Out
- 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.
Education:
Your Background
- 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.
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.
Process Development Test Engineer · LanceSoft Inc