Advanced Manufacturing Engineer
3 weeks ago
This role will support a lead manufacturing engineer during development and validation of new production lines for a new medical device at LanceSoft.
Key Responsibilities:
Support development and validation for new production processes. Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes. Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ). 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. Provide engineering support to manufacturing operations and address quality issues arising on the production floor.
Requirements:
Bachelor's Degree in a technical discipline. Minimum 4 years of experience required. Nice to Have: Master's Degree in a technical discipline. Medical Device and/or Manufacturing Experience. Experience with materials joining process, such as laser welding, ultrasonic welding, or resistance welding. Laser marking experience. Experience developing vision inspection/verification systems.
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