Senior Manufacturing Engineer

The Senior Manufacturing Engineer is responsible for leading the development, optimization, validation, and sustainment of manufacturing processes for regulated medical devices. This role partners closely with R&D, Quality, Regulatory, Supply Chain, and Production departments to ensure safe, compliant, and cost-effective manufacturing throughout the product lifecycle. The role works collaboratively to verify product performance, validate manufacturing processes, and contribute to continuous improvement initiatives.This position is based in our office in Eden Prairie, MN. Relocation assistance and visa sponsorship are not available.ROLES AND RESPONSIBILITIES-Execute the design, development, and optimization of manufacturing processes for new and existing medical devices.Participate in design changes, product updates, and sustaining engineering projects, ensuring continued compliance and performance.Support product transfer from R&D to manufacturing (NPI, scale-up, and commercialization).Identify and implement process improvements to improve yield, quality, safety, and throughputGuide supplier selection, qualification, and ongoing performance managementApply SPC, capability studies, and data analysis to monitor and improve process performancePlan, execute, and document process validation activities (IQ/OQ/PQ) in accordance with regulatory and quality system requirements.Execute standardization of manufacturing processes and workstationsSupport CAPA, NCMR, deviation investigations, and risk assessments (FMEA, pFMEA)Support capacity planning and equipment selection for growthExecute characterization studies to understand critical process parameters and establish process limits.Serve as the primary technical liaison between internal engineering and contract manufacturers for process improvements, troubleshooting, and change management.Create and execute test protocols, analyze data, and write test reports for design verification.Ensure compliance with Lean Manufacturing, Six Sigma, or Operational Excellence initiatives.Translate product requirements and design specifications into robust manufacturing processes.Define and implement process controls to ensure consistent product quality and compliance.Perform failure mode and effects analysis for both design and manufacturing.Define verification methods (inspection, analysis, testing, or demonstration) to ensure traceability to design inputs.Calibrate, preventively maintain, and keep records of equipment and tools.Ensure the company's manufacturing processes are compliant with all required regulations.Coordinate equipment maintenance, repairs, and calibrations to minimize downtime.Provide remote and on-site technical training or guidance to Contract Manufacturers and production personnel as needed.Create and execute test protocols, analyze data, and write test reports for design verification.Design or specify tooling, fixtures, and test equipment required for production processes.Perform other duties as assigned or required.MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTSBachelor's degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline.5+ years of experience in medical device product development, verification & validation, or process/manufacturing engineering.Proven experience with process validation (IQ/OQ/PQ) and statistical tools (SPC, DOE, GR&R).Proficient with CAD and fixture design.Familiarity with risk management (PFMEA, DFMEA) and process controls.Excellent verbal, written communication, especially with development and quality teams.Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.Early stage/start up experience strongly preferred.