Tool Design Engineering Manager manages the design and development of tools and machinery to facilitate and optimize manufacturing processes. Leads design reviews to determine tooling concepts, design options, testing plans, and specifications. Being a Tool Design Engineering Manager provides expert input to resolve design issues and innovate solutions. Oversees the design, fabrication, sourcing, and procurement of fixtures, jigs, gauges, cutting and forming tools, carts, racks, and other items to support production. Additionally, Tool Design Engineering Manager ensures design documentation and models for the fabrication of tools are accurately prepared. Controls budgets, costs, resource allocation, and materials required for tools. Typically requires a bachelor's degree or equivalent. Typically reports to a head of a unit/department. The Tool Design Engineering Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Tool Design Engineering Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Position Description:
Engineering Manager – Design Reliability for Medtronic, Inc. located in Brooklyn Center, MN. Support new product development and continuous improvement of commercial medical devices. Responsible for investigative and testing activities for technical assessments and compliance activities for analysis and control of potential risks, and for quantifiably predicting product/system performance. Providing work directions to reliability technicians, including creation of test procedures, and test plans and reports. Managing and supporting laboratory equipment and test systems. Lead component complaint and product failure investigations, pre and post market quality root cause analysis, Corrective and Preventive Actions (CAPA), Released Product Investigations (RPI). Navigate government and quality regulations to include FDA CFR 21 part 820 requirements and ISO 13485, ISO 9001 and ISO 14971. Utilize statistical tools and software to include DOE, ANOVA, Confidence and Tolerance Limits, Gage R&R, Capability analysis in auditing and ensuring quality outcomes. Utilize Lean Six Sigma Green belt concepts for problem solving and root cause analysis. Query, analyze, and visualize large data sets using tools like Business Objects, Microsoft Excel, and JMP. Utilize computer and software packages to include MS Office Suite, MS Project, and Minitab. Relocation assistance not available for this position. #LI-DNI.
Basic Qualifications:
Master’s degree in Mechanical, Industrial, Chemical, Biomolecular Engineering or related field and three (3) years of experience as a reliability engineer or test engineer. Must possess three (3) years of experience with each of the following: Test engineering in medical device industry; Component complaint and product failure investigations to include pre and post market quality root cause analysis, CAPA and RPI; FDA CFR 21 part 820 requirements and ISO 13485, ISO 9001 and ISO 14971; Statistical tools and software to include DOE, ANOVA, Confidence and Tolerance Limits, Gage R&R and Capability analysis; Utilize Lean Sigma concepts for problem solving and root cause analysis; Reporting tools like Business Objects and data analysis tools like Excel and JMP; Computer and software packages to include MS Project, and Minitab.