Manufacturing Engineer III
Scalence L.L.C. is seeking a Manufacturing Engineer III to enhance supplier process validations and ensure compliance with design outputs. The role involves collaborating with various teams and contract manufacturers to support quality improvements and documentation.
Responsibilities
- Review & remediate supplier process validations and PFMEA
- Ensure compliance with design outputs and risk requirements
- Perform gap analysis & change management (CAPA-related)
- Collaborate with: Design, Quality, and Supplier Engineering teams, 10–20 contract manufacturers
- Approve process/inspection validations per statistical requirements
- Support supplier quality improvements and documentation
Skills
- Bachelor's degree in Engineering
- 1–2 years manufacturing experience
- Hands-on experience with IQ / OQ / PQ (Process Validation)
- Hands-on experience with Test Method Validation (TMV)
- Strong communication skills (supplier interaction required)
- Experience working with suppliers / contract manufacturers
- Ability to travel up to 15%
- Medical device industry experience
- Knowledge of Six Sigma / statistical methods
- Project management skills
Company Overview