Sr Manufacturing Engineer - Exempt

JOB DESCRIPTIONProcess ValidationDesign of ExperimentsGauge R&REducation Required: Bachelor's degree in technical disciplineYears' Experience Required: 4+Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hoursDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Fully OnsiteWhat is your timeline for scheduling interviews? 1-2 weeksWhat product line will this person support? Ligasure ExactThis 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 RequirementsBachelor's Degree in a technical disciplineMinimum 4 years of experience required.Nice to HaveMaster's Degree in a technical disciplineMedical Device and/or Manufacturing ExperienceExperience with materials joining process, such as laser welding, ultrasonic welding, or resistance welding.Laser marking experience.Experience developing vision inspection/verification systems.