Medical Device Process Development 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

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.