Process Development Test Engineer

Lancesoft; Minnetonka (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

Lancesoft in Minnetonka, MN seeks a Process Development Test Engineer to support the development, characterization, validation, transfer, and improvement of manufacturing processes for medical devices.

You will build, modify, and troubleshoot fixtures and tooling, conduct DOE studies, qualify equipment, and maintain production documentation while collaborating with R&D, Quality, Operations and Supply Chain to deliver robust, compliant processes.

Qualifications

• Associate degree or technical diploma in a mechanical/manufacturing discipline.
• 3+ years of hands-on technician or process-development experience.
• Experience in medical devices or regulated industry (GMP/ISO/FDA) preferred.
• Experience with fixture fabrication, machining, rapid prototyping, or precision assembly.
• Strong problem-solving and data documentation abilities.

Responsibilities

• Support development, characterization, validation, transfer, and improvement of processes.
• Build, modify, troubleshoot, and evaluate fixtures, tooling, and assemblies.
• Perform DOE studies, equipment qualification, process validation, and production-ready builds.
• Create and maintain manufacturing documentation (WIs, routers, BOMs, process specs).
• Identify risks and opportunities to improve safety, quality, yield, cycle time, cost.
• Collaborate with R&D, Operations, Quality, and Supply Chain to meet schedules.

Skills

Mechanical aptitude

Analytical problem-solving

Reading engineering drawings

Measurement & inspection tools

Communication skills

Multitasking / prioritization

MS Office

Minitab

Education

Associate degree or technical diploma in mechanical/manufacturing

3+ years hands-on process-development/manufacturing engineering

Experience in medical devices or regulated industry (GMP/ISO/FDA) preferred

Tools

Calipers

Micrometers

Force gauges

Torque tools

Job description

Title: Process Development Test Engineer

Location: Minnetonka, MN

Duration: 12 Months 100% Onsite

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

• 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

• 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.