Sr Manufacturing Engineer – Exempt

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

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.

Minimum Requirements

• Bachelors Degree in a technical discipline
• Minimum 4 years of experience required.

Nice to Have

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