Senior Manufacturing Engineer

Infotree Global Solutions; Lafayette (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Infotree Global Solutions is seeking an Advanced Manufacturing Engineer to support the lead engineer during implementation of design changes to a medical device (electronic hardware). The role involves validating new production processes, managing BOM configurations in PLM, and integrating components with ERP/MRP systems.

The position requires a Bachelor’s degree in a technical discipline and at least 4 years of experience. Experience in electronics manufacturing or medical devices is preferred.

Qualifications

• Bachelor’s degree in a technical discipline required.
• Minimum 4 years of experience in manufacturing engineering.
• Experience with medical device manufacturing or electronics is a plus.

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.
• Generate documents and BOM structures to support service depots.
• Provide engineering support to manufacturing operations and address quality issues arising on the production floor.

Skills

Process Validation

PLM usage

ERP systems

Education

Bachelor's degree in a technical discipline

Job description

12+ months

JOB DESCRIPTION

This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during implementation of design changes to a medical device (electronic hardware).

Responsibilities include, but are not limited to:

• 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.

Top 3 technical skills that are required for the role:

• 1. Process Validation
• 3. Use of PLM and ERP systems as manufacturing engineer

Education Required: Bachelor’s degree in a technical field

• Bachelor’s Degree in a technical discipline

Years’ Experience Required: 5 years minimum

• 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