Senior Manufacturing Engineer

Title: Senior Manufacturing Engineer



Location: Lafayette, CO

Pay Rate: $70-75/hr on W2



Duration: 24+ months with Possible Extension

Position Summary

We are seeking a Senior Manufacturing Engineer (Advanced Manufacturing Engineer) to support the introduction and implementation of a new electrosurgical medical device within a manufacturing environment. In this role, you will partner with the Lead Manufacturing Engineer to develop, validate, and optimize manufacturing processes while ensuring compliance with quality and regulatory requirements.

The ideal candidate has strong experience in manufacturing process validation, test method validation, and manufacturing systems, along with a solid background supporting new product introductions in a regulated manufacturing environment.

Key Responsibilities

• Support the development, implementation, and validation of new manufacturing processes for medical device production.
• Develop and execute equipment qualification and process validation activities, including IQ, OQ, and PQ.
• Perform Test Method Validation (Gauge R&R) and software validation for hardware test systems.
• Manage and maintain product Bill of Materials (BOMs) within the PLM system.
• Integrate new product components into manufacturing ERP/MRP systems.
• Perform statistical analysis to evaluate process capability, repeatability, and manufacturing performance.
• Create and maintain manufacturing documentation including:
  • Validation protocols and reports
  • Manufacturing work instructions
  • Engineering change orders (ECOs)
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Statistical reports and technical documentation
• Develop BOM structures and supporting documentation for service depots.
• Provide engineering support to manufacturing operations and troubleshoot production and quality issues.
• Collaborate with cross-functional teams including Manufacturing, Quality, Supply Chain, and Product Development to support successful product launches.

Required Qualifications

• Bachelor's degree in Engineering or another technical discipline.
• Minimum 5 years of manufacturing engineering experience.
• Strong experience with:
  • Process Validation (IQ/OQ/PQ)
  • Test Method Validation (Gauge R&R)
  • PLM and ERP/MRP systems in a manufacturing environment
• Experience creating engineering documentation and supporting manufacturing change processes.
• Strong analytical, problem-solving, and statistical analysis skills.
• Ability to work onsite in Lafayette, CO.

Preferred Qualifications

• Master's degree in Engineering or a related technical discipline.
• Experience within the Medical Device industry.
• Experience supporting electronic hardware manufacturing.
• Background in New Product Introduction (NPI).
• Experience with regulated manufacturing environments (FDA/ISO 13485).

Top 3 Required Technical Skills

1. Process Validation (IQ/OQ/PQ)
2. Test Method Validation (Gauge R&R)
3. PLM and ERP/MRP systems experience in a manufacturing engineering environment