Sr Manufacturing Engineer - Exempt
Join our team in Lafayette, CO, a vibrant community nestled against the backdrop of the stunning Rocky Mountains. As a key player in our manufacturing operations, you'll have the opportunity to work in a dynamic environment that fosters innovation and growth. Enjoy the perks of living in a picturesque location while advancing your career in the manufacturing engineering field.Top 3 Technical Skills RequiredProcess ValidationTest Method Validation (Gauge R&R)Use of PLM and ERP systems as a manufacturing engineerEducation & ExperienceBachelor's degree in a technical fieldMinimum 5 years of experienceWork Schedule40 hours per week, onsite.Interview TimelineInterviews will be scheduled one week after posting.Product Line SupportElectrosurgical HardwarePosition OverviewThis role will support a lead manufacturing engineer during the implementation of design changes to a medical device (electronic hardware).ResponsibilitiesSupport development and validation for new production processes.Manage product BOM configurations in PLM system.Integrate new components with manufacturing ERP/MRP systems.Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).Perform Test Method Validation and Software Validation for hardware test systems.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.Generate documents and BOM structures to support service depots.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 requiredNice to HaveMaster's Degree in a technical disciplineMedical Device and/or Manufacturing ExperienceExperience in an electronics manufacturing environment