Senior Manufacturing Engineer- Medical Device- Hudson, WI

Job TitleSenior Manufacturing EngineerAbout Our ClientOur client is a rapidly growing engineering and manufacturing organization that partners with some of the world's leading medical device companies to develop and produce highly complex components and assemblies. With a strong focus on innovation, advanced manufacturing technologies, and operational excellence, the company plays a critical role in bringing next-generation medical products from concept to commercialization. The organization offers a collaborative, fast-paced environment where engineers have the opportunity to work on cutting-edge technologies that help improve patient outcomes and advance healthcare worldwide.Job DescriptionLead new and existing medical device manufacturing programs from development through production. Manage project schedules, manufacturing readiness activities, and technical deliverables. Serve as a primary technical liaison with customers and cross-functional stakeholders. Collaborate with engineering, operations, quality, and multi-site teams to support product transfers and launch activities. Design and develop manufacturing processes, tooling, fixtures, and workholding solutions to meet quality, capacity, and safety requirements. Provide day-to-day production support through troubleshooting, process optimization, equipment improvements, and operator training. Create and maintain manufacturing documentation in compliance with established quality system requirements. Drive continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma, and other structured problem-solving methodologies. Analyze technical and operational data to identify opportunities for process improvement and operational excellence. Lead process validation efforts, including IQ/OQ/PQ, Test Method Validations (TMVs), equipment qualification and commissioning, and preventive maintenance programs. Prepare engineering reports and communicate technical findings to customers, leadership teams, and internal stakeholders. Support equipment and process selection decisions through engineering analysis and data-driven recommendations.The Successful ApplicantA successful Senior Manufacturing Engineer should have: Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related technical field. Minimum of 6 years of manufacturing engineering experience, preferably within a regulated industry. Experience with New Product Introduction (NPI), Product Development Processes (PDP), and manufacturing scale-up activities. Proven ability to solve complex technical problems using sound engineering principles and structured methodologies. Strong statistical analysis experience, including Design of Experiments (DOE), Process Capability Analysis, Regression Analysis, Equivalence Studies, and ANOVA. Proficiency with SolidWorks or equivalent CAD software for tooling and fixture design. Strong understanding of GD&T and engineering drawing creation. Experience utilizing structured problem-solving methods such as Six Sigma, DMAIC, A3, and 5 Whys. Excellent technical writing skills with experience creating manufacturing procedures, validation protocols, and engineering reports. Strong project management and organizational skills. Excellent communication and presentation abilities with experience interfacing with customers, leadership teams, and cross-functional stakeholders. Ability to balance multiple priorities and drive execution in a dynamic environment.What's on OfferCompetitive base salary with annual performance-based bonus opportunity. Comprehensive medical, dental, and vision insurance. 401(k) with company match. Generous paid time off and company holidays. Life insurance and disability coverage. Employee assistance and wellness programs. Professional development and training opportunities. Career growth within a rapidly expanding medical device manufacturing organization. Exposure to cutting-edge technologies and innovative product development programs. Collaborative, team-oriented culture focused on continuous improvement and operational excellence.Job summarySector: Engineering & ManufacturingSub Sector: Production, ManufacturingIndustry: Industrial / ManufacturingWhere: HudsonContract Type: PermanentConsultant name: Jack DonahueJob Reference: JN-072026-7075450