Sr Manufacturing Engineer - Exempt

Join our dynamic team in Lafayette, CO, a vibrant location that offers a perfect blend of work-life balance and professional growth opportunities. We are seeking a dedicated individual to support our electrosurgical hardware product line as part of an advanced manufacturing engineering team.

Top 3 Technical Skills Required:

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

Education and Experience:

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

Work Schedule:

Full-time, 40 hours per week, onsite.

Responsibilities:

• 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.

Nice to Have:

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

Interviews will be scheduled one week after posting. Don't miss the chance to be part of a team that is at the forefront of medical device innovation!