Medical Device Manufacturing Engineer - Process Validation

Grove Technical Resources, Inc.; Colorado; On-site; USD 90,000 - 120,000; Full time

Job summary

Grove Technical Resources, Inc. is seeking an experienced Advanced Manufacturing Engineer to support the implementation of design changes for medical device electronic hardware.

You will partner with a Lead Manufacturing Engineer and provide technical support across process validation, test method validation, manufacturing systems, and production support. This role emphasizes hands-on validation work, BOM management in PLM/ERP systems, and collaboration with cross-functional teams to deliver

Qualifications

• Bachelor’s degree in engineering or another technical discipline.
• Minimum 4 years of relevant experience; 5+ years preferred.
• Experience with process validation and manufacturing engineering.
• Experience with Test Method Validation / Gauge R&R.
• Experience using PLM and ERP/MRP systems in a manufacturing environment.

Responsibilities

• Support the development and validation of new manufacturing processes.
• Develop and execute process validation plans, including IQ/OQ/PQ.
• Perform statistical analysis to evaluate process repeatability and capability.
• Lead/support Test Method Validation and Gauge R&R activities.
• Support software validation for hardware test systems.
• Manage product BOM configurations within PLM systems.
• Integrate new components and BOM information into ERP/MRP systems.
• Create and maintain manufacturing documentation, including engineering protocols and reports.
• Process risk documentation / PFMEA.
• Manufacturing instructions
• Statistical analysis
• Generate documentation and BOM structures to support service depots.
• Provide engineering support to manufacturing operations.
• Investigate and resolve quality issues on the production floor.
• Collaborate with cross-functional teams during design changes and manufacturing implementation.

Skills

Process Validation

PLM & ERP/MRP Systems in Manufacturing

Education

Bachelor’s degree in engineering or technical discipline

Tools

PLM software

ERP/MRP systems

Job description

Grove Technical Resources, Inc. is seeking an experienced Advanced Manufacturing Engineer to support the implementation of design changes for medical device electronic hardware.

You will partner with a Lead Manufacturing Engineer and provide technical support across process validation, test method validation, manufacturing systems, and production support. This role emphasizes hands-on validation work, BOM management in PLM/ERP systems, and collaboration with cross-functional teams to deliver