Principal Mechanical Design Engineer
- Design new parts and assemblies using CAD, generate CAD models, assemblies, and drawings from engineering requirements
- Create and lead processing change orders to release or modify existing mechanical models and drawings and bills of materials.
- Apply principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials, and confirm correctness using engineering methodologies and tools such as FEA, GD&T, etc.
- Develop and complete documentation deliverables including design description reports, design models, drawings and engineering analysis reports.
- Works with suppliers, manufacturing and service to design for manufacturability and serviceability.
- Works with test engineering to support creation of test protocols and reports for verification ad validation testing.
- Researches and analyzes design and experimental data to understand technical issues and set a direction for issue resolution.
- Effectively communicates project technical status, time and schedule for tasks including estimates to complete.
- Completes engineering tasks in a timely fashion, and manages time budgets for tasks. Identifies and efficiently resolves technical problems and issue.
- Bachelor's degree in Engineering, Mechanical preferred or equivalent
- Minimum 5+ years of experience in new product development, and have at least participated in one medical device project from concept to market introduction demonstrating experience and familiarity with ISO 13485, IEC 60601-1 and ISO 14971.
- Direct experience with the product development process ranging from requirements development, prototyping, design for manufacturing, verification and product release.
- Experience in medical device or other regulated industries.