Guy Goblirsch

Background

About Guy Goblirsch

Title: Project Lead/Project Manager Senior Mechanical Design Engineer Human Factors Engineer Systems Engineer Professional Skills and Qualifications: PRODUCT DEVELOPMENT - LEADERSHIP - Project lead on technical design projects. Have lead from initial concept through post-market review - Project Manager on multiple Medical Device development projects. Tasks include: creating project proposal statements of work, team selection, scheduling, budget creation and management, tasking, team meetings and weekly client interactions - Working closely with software engineers to design and develop source code in C/C++- Managing issue tracking systems and leading scum meetings in Agile-like development process - Creating Project Plans and associated domain planning (Human Factors, Verification/Validation, Risk Management, Design Transfer) PRODUCT DEVELOPMENT - ENGINEERING - CAD modeling and Drawing - Prototyping (Rapid Prototyping, machining skills)- Design and execution of experiments and development of test fixtures - Design analysis (FEA, numerical analysis, designing to meet product requirements) HUMAN FACTORS- Design and lead formative studies to evaluate products at multiple stages of the design process - Design and lead Summative HF studies to test critical tasks and validate user needs - Develop prototypes for both software applications (UI/UX prototyping) and device hardware to test with users - Identify User Needs and create User/Environment profile - Create Task Analysis, Fault-Tree Analysis (FTA), System Architecture to define task scenarios and user workflow DESIGN CONTROLS- Developing and executing Verification and Validation Protocols - Writing Verification and Validation Reports - Design Reviews (Technical, In-phase, Design Change)- Risk evaluation (dFMEA, uFMEA, Preliminary Hazard Analysis)- Writing/Developing Product Requirements and LL Requirements (with tracing)- Design Transfer activities (ECOs) PRODUCTION AND MANUFACTURING - Knowledge and experience with numerous methods (Machining, Molding, Casting, 3D-printing)- Quality Control, 6-Sigma manufacturing TECHNICAL/SOFTWARE SKILLS - SolidWorks / NX - SQL - MatLab - LABView - ANSYS (FEA)- Minitab - Microsoft Office Tools OTHER SKILLS - Strong oral communication skills - Writing/ Technical Writing - Leadership capabilities - Presentation skills (Powerpoint, posters, oral presentations)- Networking skills "Whether you think you can or think you can't, you're right."-Henry Ford