Test Engineer

Mantu; Warsaw (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

Mantu is seeking a Process Development Test Engineer in Indiana to support development, validation, transfer, and continuous improvement of manufacturing and assembly processes for medical devices. You will work hands-on with fixtures, tooling, equipment, and process documentation.

The role collaborates with R&D, Operations, Quality, Supply Chain, and external suppliers to ensure robust processes, data-driven decision making, and successful process transfers from development to production.

Qualifications

• Associate degree or technical diploma or certificate in Mechanical/Manufacturing/EME or related technical discipline.
• 3+ years hands-on experience in process development, manufacturing engineering, or related field.
• Experience reading drawings, tolerances, and work instructions; GD&T knowledge is a plus.
• Proficient in using measurement tools and data for problem-solving and process validation.

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 DOE, equipment qualification, process validation, and production‑equivalent builds with clear documentation.
• Create and maintain controlled manufacturing documentation (work instructions, routers, BOMs, process specs, tooling records, test methods).
• Investigate process issues, nonconformances, build anomalies, and sources of variation using structured problem-solving and data.

Skills

Mechanical aptitude

Reading engineering drawings

Problem solving

Documentation

Lean Manufacturing

Statistics (Minitab)

Education

Associate degree or technical diploma or certificate

Tools

Calipers

Micrometers

Force gauges

Torque tools

Minitab

Job description

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.