Senior Medical Device Manufacturing Engineer

Planet Pharma; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Lead Manufacturing Engineer to support the implementation of design changes to a medical device (electronic hardware) in Colorado. You will assist development and validation for new production processes, manage BOM configurations in PLM, and integrate new components with ERP/MRP systems.

You will develop and execute plans with statistical analysis to evaluate process repeatability through IQ/OQ/PQ, perform Test Method Validation and Software Validation for hardware

Qualifications

• Bachelor's degree in a technical discipline.
• Minimum 4 years of experience.
• Master's degree in a technical discipline (nice to have).
• Medical Device and/or Manufacturing experience (nice to have).
• Electronics manufacturing experience (nice to have).

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 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 on the production floor.

Skills

Statistical analysis

Documentation

Engineering support

Process validation

BOM configurations

Education

Bachelor's degree in a technical discipline

Master's degree (nice to have)

Tools

PLM system

ERP/MRP systems

Job description

Planet Pharma is seeking a Lead Manufacturing Engineer to support the implementation of design changes to a medical device (electronic hardware) in Colorado. You will assist development and validation for new production processes, manage BOM configurations in PLM, and integrate new components with ERP/MRP systems.

You will develop and execute plans with statistical analysis to evaluate process repeatability through IQ/OQ/PQ, perform Test Method Validation and Software Validation for hardware