We are looking for an experienced Mechanical Design Engineer with strong medical device product development expertise to drive design, compliance, and cross-functional engineering efforts for Class II & III devices.
Key Responsibilities
- Strong understanding of Medical Device product development, preferably with Design Control experience for Class II & III devices (FDA 21 CFR 820.30).
- Well-versed with medical device compliances, regulations & standards such as ISO 13485, 21 CFR 820, ISO 14971.
- Good knowledge of Design Control processes, including design inputs, reviews, outputs, and change management.
- Hands-on expertise in mechanical engineering design with experience in plastic injection molding, die-casting, sheet-metal forming, and machining.
- Skilled in GD&T, statistical tolerance analysis, and SPC practices.
- Ability to apply DfM and DfA principles in product development.
- Review, modify, and validate 3D models and 2D drawings for NPD and sustenance projects.
- Familiar with Product Lifecycle Management (PLM) and tools such as Agile, Windchill, Teamcenter.
- Knowledge of requirements engineering, risk analysis, and V&V activities.
- Prepare and maintain DHF documentation and ensure compliance.
- Participate actively in Design Reviews across design inputs/outputs.
- Work with cross-functional teams for approvals, deliverables, and PLM Change Orders.
- Provide engineering support, guidance, and clear communication to internal teams.
- Create regular status updates and presentations for senior leadership.
Preferred Skills & Tools
- ISO 13485, 21 CFR 820, ISO 14971
- CAD tools: SolidWorks, Creo, AutoCAD
- PLM tools: Agile, Windchill, Teamcenter
- Tools: Power BI, Minitab, Smartsheet, MS Office
- Strong communication, analytical thinking, and attention to detail.
