Sr Manufacturing Engineer - Exempt

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.

Responsibilities

• 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, 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.

Minimum Requirements

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

Nice to Have

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