Change Management, Cross-Functional, Engineering Change Management, Engineering Management, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Manufacturing, Mechanical Design, Mechanical Engineering, Medical Equipment, Medical Office Administration, PTC Creo, Product Development, Quality System Requirements (QSR), Research & Development (R&D), SolidWorks, Tolerance Analysis
Job Summary:- Lead mechanical design and development activities for medical device programs
- Strong focus on 3D stack-up and tolerance analysis
- Drive New Product Development (NPD) lifecycle execution
- Ensure engineering deliverables are met with high technical ownership
Roles & Responsibilities:- Perform detailed 3D stack-up and tolerance analysis
- Support medical device design and development activities
- Execute NPD lifecycle deliverables from concept to release
- Manage engineering change processes (ECO/ECR)
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing)
Education & Experience:- 5+ years of experience in mechanical design (medical device preferred)
- Strong expertise in 3D stack-up and tolerance analysis
- Proficiency in CAD tools (Creo / SolidWorks / NX or equivalent)
- Experience in New Product Development (NPD) lifecycle
- Knowledge of engineering change management (ECO/ECR)
- Experience in regulated environments (ISO 13485 / FDA QSR preferred)
- Understanding of DFM/DFA principles
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Katalyst Healthcares & Life Sciences