NPI Engineering Section Lead

JOB PURPOSEResponsible for leading the engineering team that transitions products from design and development into manufacturing ensuring production sustainability, process validations, projects, quality metrics and investigations assuring the sustaining of production lines according to quality compliance regulations.
MAJOR RESPONSIBILITIESLead New Product Introduction (NPI) and Production Transfer Activities.Ensure Manufacturing Process Validation and Compliance.Drive Production Sustainability and Continuous Improvement (Six Sigma DMAIC, DOE’s, Lean tools).Manage Quality Metrics (NCR, CAPA, Scrap Rate, Yield), Investigations, and Corrective Actions.Lead Engineering Projects and Cross-Functional Initiatives.Develop and Lead the Engineering Team.
MINIMUM QUALIFICATIONSBachelor’s degree in engineering.7+ years of work experience in medical industry. Catheter experience preferred.Fluent in spoken and written business English.Strong decision-making and problem-solving skills.Effective budgeting and performance management.Strong validation medical manufacturing process experience as a lead.Strong statistical techniques knowledge (DOE, SPC, etc.) is required plus experience with continuous improvement methodologies.Software: Minitab, AutoCad & Solidworks.Knowledge in CAPEX, Budget control and COGS.Management and communication of Projects timeline to key stakeholders including but not limited to Business Development, Process Development, Quality and Supply Chain.Coordinating & leading customer and internal meetings.Leading and managing the project’s budget and performing CAPEX approval requirements.Good time management skills.People management and development skills.
PREFERRED QUALIFICATIONSMaster’s degree in Business Administration, Project Management, Medical Devices, Production, Finance and/or another related field.2 to 5 Years in leadership positions in Manufacturing Engineering or related field at medical device Companies.Six Sigma Black Belt experience.CQE certification is nice to have.Black Belt, Green Belt or Yellow Belt certification is a plus.