Senior Manufacturing Engineer (35951)

Senior Manufacturing Engineer Direct Hire Holly, Mi area $100-115k JOB SUMMARY Lead contract manufacturing projects from concept through production, ensuring robust process design, manufacturability, and ongoing improvement. Support production teams, drive continuous improvement, maintain compliant documentation, and collaborate directly with customers and cross‑functional teams. Ensure all processes and specifications meet QMS, FDA 21 CFR Part 820, and ISO 13485 requirements. RESPONSIBILITIES: Contract Design & Development Lead design and development for OEM/contract manufacturing projects.Manage prototypes, first articles, design risk mitigation, and product testing.Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs).Verify design outputs vs. inputs and support quality planning.Lead project timelines, milestones, and cross‑functional meetings. Contract Manufacturing Lead (OEM projects) Evaluate new or revised product designs for manufacturability and process fit.Work with OEM engineers to refine requirements and ensure production feasibility. Manufacturing Process Development and Documentation Develop, validate, and document production processes for repeatability and efficiency.Design/validate tools, fixtures, molds, and work instructions.Conduct PFMEAs, process capability studies, and prototype builds.Train production personnel on new processes.Support and lead where required assessment and qualifications of suppliers.Support and lead where required sourcing and qualification of materials. Continuous Improvement Apply Lean principles to reduce waste and improve efficiency.Lead/participate in root‑cause investigations and corrective actions.Develop error‑proofing tools, test new materials, and assess ROI for improvements.Implement changes through Change Control and CAPA. Production Support Resolve production issues, review documentation, and initiate updates.Participate in NCR/MRB activities and help define acceptance criteria. Other Duties Represent Company with professionalismTravel as needed (domestic and international)Champion Company vision, purpose, and valuesAll other duties, as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. REQUIREMENTS Bachelor’s in Mechanical or Industrial Engineering (or equivalent experience).5+ years in manufacturing/mechanical engineering and product development.Strong SolidWorks/EPDM skills; ERP experience (Global Shop preferred).Lean familiarity and strong analytical/problem‑solving skills.Excellent communication and documentation skills.Highly organized, quality‑focused, and collaborative. Additional Preferred Qualifications Medical device experience.CNC programming experience.Technical writing experience.Lead design and development for OEM/contract manufacturing projects.Manage prototypes, first articles, design risk mitigation, and product testing.Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs).Verify design outputs vs. inputs and support quality planning.Lead project timelines, milestones, and cross‑functional meetings. Contract Manufacturing Lead (OEM projects) Evaluate new or revised product designs for manufacturability and process fit.Work with OEM engineers to refine requirements and ensure production feasibility. Manufacturing Process Development and Documentation Develop, validate, and document production processes for repeatability and efficiency.Design/validate tools, fixtures, molds, and work instructions.Conduct PFMEAs, process capability studies, and prototype builds.Train production personnel on new processes.Support and lead where required assessment and qualifications of suppliers.Support and lead where required sourcing and qualification of materials. Continuous Improvement Apply Lean principles to reduce waste and improve efficiency.Lead/participate in root‑cause investigations and corrective actions.Develop error‑proofing tools, test new materials, and assess ROI for improvements.Implement changes through Change Control and CAPA. Production Support Resolve production issues, review documentation, and initiate updates.Participate in NCR/MRB activities and help define acceptance criteria. Other Duties Represent Company with professionalismTravel as needed (domestic and international)Champion Company vision, purpose, and valuesAll other duties, as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. REQUIREMENTS Bachelor’s in Mechanical or Industrial Engineering (or equivalent experience).5+ years in manufacturing/mechanical engineering and product development.Strong SolidWorks/EPDM skills; ERP experience (Global Shop preferred).Lean familiarity and strong analytical/problem‑solving skills.Excellent communication and documentation skills.Highly organized, quality‑focused, and collaborative. Additional Preferred Qualifications Medical device experience.CNC programming experience.Technical writing experience. ,