Sr Manufacturing Engineer
IntePros
Title: Sr Manufacturing Engineer
Location: Lafayette, CO 80026 (Onsite)
Duration: 2-Year Contract (Possible extension) Job Summary:
We are seeking an experienced Senior Manufacturing Engineer to support the implementation and launch of a new electronic medical device within client's Electrosurgical Hardware product line. This role will partner with the Lead Manufacturing Engineer to develop, validate, and optimize manufacturing processes while ensuring compliance with quality and regulatory standards.
The ideal candidate will have a strong background in process validation (IQ/OQ/PQ) , Test Method Validation (Gauge R&R) , and hands-on experience using PLM and ERP/MRP systems in a manufacturing environment. Key Responsibilities
Location: Lafayette, CO 80026 (Onsite)
Duration: 2-Year Contract (Possible extension) Job Summary:
We are seeking an experienced Senior Manufacturing Engineer to support the implementation and launch of a new electronic medical device within client's Electrosurgical Hardware product line. This role will partner with the Lead Manufacturing Engineer to develop, validate, and optimize manufacturing processes while ensuring compliance with quality and regulatory standards.
The ideal candidate will have a strong background in process validation (IQ/OQ/PQ) , Test Method Validation (Gauge R&R) , and hands-on experience using PLM and ERP/MRP systems in a manufacturing environment. Key Responsibilities
- Develop, implement, and validate new manufacturing processes for electronic medical devices.
- Execute Process Validation (IQ/OQ/PQ) to ensure manufacturing processes are capable, repeatable, and compliant.
- Perform Test Method Validation , including Gauge R&R (Measurement System Analysis) , for hardware test systems.
- Manage and maintain Bill of Materials (BOMs) and product configurations within PLM systems .
- Integrate new products and components into ERP/MRP systems.
- Create and maintain engineering documentation, including:
- Support equipment qualification and manufacturing process improvements.
- Provide engineering support to production by troubleshooting manufacturing and quality issues.
- Collaborate with cross-functional teams including Manufacturing, Quality, R&D, Supply Chain, and Operations.
- Generate documentation and BOM structures to support manufacturing and service operations.
- Bachelor's degree in Engineering or another technical discipline.
- Minimum 5 years of Manufacturing Engineering experience.
- Strong experience with Process Validation (IQ/OQ/PQ) .
- Experience performing Test Method Validation and Gauge R&R (MSA) .
- Experience using PLM and ERP/MRP systems within a manufacturing environment.
- Experience with statistical analysis and manufacturing documentation.
- Strong problem-solving and troubleshooting skills.
- Excellent communication and cross-functional collaboration abilities.
- Master's degree in Engineering or a related technical discipline.
- Experience in the Medical Device industry.
- Experience in an Electronics Manufacturing environment.
- Knowledge of FDA-regulated manufacturing and quality systems.
- Experience with PFMEA, engineering change management, and product transfers.
Vacancy posted 1 day ago
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