Sr Manufacturing Engineer - Exempt

Join our team in Lafayette, CO, a vibrant community nestled against the backdrop of the stunning Rocky Mountains. As a key player in our manufacturing operations, you'll have the opportunity to work in a dynamic environment that fosters innovation and growth. Enjoy the perks of living in a picturesque location while advancing your career in the manufacturing engineering field.

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

• Bachelor’s degree in a technical field
• Minimum 5 years of experience

40 hours per week, onsite.

Interviews will be scheduled one week after posting.

Electrosurgical Hardware

This role will support a lead manufacturing engineer during the implementation of design changes to a medical device (electronic hardware).

• Support development and validation for new production processes.
• Manage product BOM configurations in 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