Test Engineer

Process Development Test Engineer

🏢 Work model: 100% on site

💼 Contract type: Freelance. C2C Contract

Position summary

Our client is looking for a Process Development Test Engineer to support the development, characterization, validation, transfer, and continuous improvement of manufacturing and assembly processes for medical devices and related subsystems.

The successful candidate will perform hands-on technical work involving fixtures, tooling, equipment, assemblies, engineering studies, process validation, production documentation, and manufacturing process improvements. The role will collaborate closely with R&D, Operations, Quality, Supply Chain, and external suppliers.

Main responsibilities

• Build, modify, troubleshoot, and evaluate prototype and production processes, fixtures, tooling, equipment, and electromechanical assemblies.
• Define assembly methods, develop process parameters, identify critical variables, and support process characterization and capability studies.
• Execute engineering studies, design of experiments, equipment qualification, process validation, and production-equivalent builds while documenting results clearly.
• Create and maintain controlled manufacturing documentation, including work instructions, routers, bills of material, process specifications, tooling records, and test methods.
• Investigate process issues, nonconformances, build anomalies, and sources of variation using structured problem-solving and objective data.
• Support process transfers from R&D to Operations through operator training, build support, equipment maintenance, issue resolution, documentation readiness, and collaboration with cross-functional teams.

Qualifications

• Associate degree, technical diploma, or certificate in Mechanical, Manufacturing, Electromechanical, Industrial Engineering, or a related technical discipline. Equivalent practical experience may be considered.
• Minimum of 3 years of relevant hands-on experience in process development, manufacturing engineering, engineering testing, production support, or a related technical field.
• Strong mechanical aptitude with experience using tools, fixtures, manufacturing equipment, production aids, and electromechanical assemblies.
• Ability to read and interpret engineering drawings, specifications, tolerances, and work instructions. Knowledge of GD&T is an advantage.
• Experience using measurement and inspection equipment such as calipers, micrometers, force gauges, torque tools, and laboratory instruments.
• Strong problem-solving, documentation, communication, and organizational skills, with knowledge of Lean Manufacturing, root-cause analysis, process capability, validation, Microsoft Office, and statistical tools such as Minitab.

Experience with medical devices, GMP, ISO, FDA, NPI, manufacturing transfer, equipment qualification, fixture fabrication, machining, rapid prototyping, adhesive processes, precision assembly, capability studies, or measurement-system analysis is considered an asset.