LanceSoft
This position is for a Manufacturing Engineer. This role will support a lead manufacturing engineer during the development and validation of new production lines for a new medical device.
Responsibilities
- Support development and validation for new production processes.
- Manage product BOM configurations in the PLM system.
- Develop and characterize the manufacturing process window and secure process capability across all variations 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.
- Bachelor's Degree in a technical discipline.
- Minimum 4 years of experience required.
- Master's Degree in a technical discipline.
- Medical Device and/or Manufacturing Experience.
- Experience with materials joining processes, such as laser welding, ultrasonic welding, or resistance welding.
- Laser marking experience.
- Experience developing vision inspection/verification systems.
- Experience in an electronics manufacturing environment.
- Process Validation
- PLM Experience
- Gauge R&R
- Years of Experience Required: 4 years minimum
- Work Schedule: 40 hours/week
- Location: 100% onsite
- Interview Timeline: Next couple of weeks
- Product Line Supported: Robotic Instruments