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LanceSoft

LanceSoft is hiring: Sr Manufacturing Engineer - Exempt in Lafayette

LanceSoft, Lafayette, CO, United States


JOB DESCRIPTION
Process Validation
Design of Experiments
Gauge R&R
Education Required: Bachelor's degree in technical discipline
Years' Experience Required: 4+
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Fully Onsite
What is your timeline for scheduling interviews? 1-2 weeks
What product line will this person support? Ligasure Exact

This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during development and validation of a new production lines for a new medical device. Responsibilities include, but are not limited to:
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.
Minimum 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.