Sr Manufacturing Engineer - Exempt

Electrosurgical Hardware Development Engineer

Join our dynamic team in Lafayette, CO, where you will have the opportunity to work in a cutting-edge environment focused on the development of electrosurgical hardware. This role offers the chance to lead technical projects and innovate in the field of manufacturing engineering.

• Management of Manufacturing Equipment Development Strategy
  • Leading and organizing a project team for manufacturing equipment development.
  • Creating and allocating tasks to team members. Monitor progress on all deliverables.
  • Maintain schedule for manufacturing deliverables and work with Project Manager to integrate deliverables into overarching program schedule.
  • Work with cross-functional team to create requirements flow down to connect product specifications to manufacturing test processes.
• Support Qualification of New Production Line
  • 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, 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