Sr Manufacturing Engineer - Exempt

Join our dynamic team in Lafayette, CO, where innovation meets precision in the world of electrosurgical hardware. We are seeking a skilled professional to support the implementation of a new medical device. This is a fantastic opportunity to advance your career in a thriving and supportive environment.

• Manufacturing Engineering
• Process Validation
• Test Method Validation

• Process Validation
• Test Method Validation (Gauge R&R)
• Use of PLM and ERP systems as a manufacturing engineer

• Support development and validation for new production processes.
• Manage product BOM configurations in the PLM system.
• Integrate new components with manufacturing ERP/MRP systems.
• Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
• Perform Test Method Validation and Software Validation for hardware test systems.
• Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders, and statistical analysis.
• Generate documents and BOM structures to support service depots.
• Provide engineering support to manufacturing operations and address quality issues arising on the production floor.

• Bachelor’s Degree in a technical discipline
• Minimum 4 years of experience required

• Master’s Degree in a technical discipline
• Medical Device and/or Manufacturing Experience
• Experience in an electronics manufacturing environment

Commit to a full-time schedule of 40 hours per week, working onsite in our state-of-the-art facility. Interviews will be scheduled one week after posting, so apply now to become a part of our innovative team.