
Expert Designer
21 hours ago
As a Mechanical Design Expert, you will be part of a high-impact global organization that works across all modalities. The Supplier Transfer Excellence Team (STET) has been established as an entrepreneurial organization that focuses on fast-paced, high-quality portfolio transfers within the global supply base to mitigate risk and maximize profitability.
Your role in this team involves leading, executing, and providing technical guidance on modified launch design (MLD) projects for class devices and change. You will also be responsible for end-to-end engineering support for supplier-initiated change requests, including part design, tooling, and manufacturing location changes. Additionally, you will follow design controls governed by FDA, have hands-on experience with Design verification, Validation, protocol documentation, and excellent communication skills to lead CFT teams.
- Lead MLD projects for class devices and change
- Provide technical guidance on MLD projects
- End-to-end engineering support for supplier-initiated change requests
- FOLLOW DESIGN CONTROLS GOVERNED BY FDA
- HANDS-ON EXPERIENCE WITH DESIGN VERIFICATION, VALIDATION, PROTOCOL DOCUMENTATION
- EXCELLENT COMMUNICATION SKILLS TO LEAD CFT TEAMS
You will conduct DFM, DFA reviews with suppliers and have hands-on experience with Windchill. To succeed in this role, you should have the following skills and experience:
Required Skills and Qualifications- Bachelor's degree in Mechanical Engineering with 8-12 years of proven design engineering and product development experience
- Experience supporting supplier transfer & sustaining projects
- Demonstrated strong analytical and problem-solving skills
- Knowledge of manufacturing quality systems and working in a regulated industry
- Experience with geometric dimensioning and tolerance
- Strong English written and verbal communication skills required
- Create 3D models, assembly, and detailing including drawing conversions
- Apply GD&T and perform Tolerance stack-up analysis for components/Sub-system
- Review and ensure adequacy of supplier part qualification activities
- Performing hand calculations for design feasibility
- Shall have hands-on expertise in Engineering change Management
- Provide technical support to suppliers & other departments to fulfill project/productions
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