We are seeking a Mechanical Design Engineer to design and develop mechanical components and systems for medical devices. The role involves creating 3D CAD models, performing tolerance stack-up analysis, conducting testing and validation, and ensuring compliance with regulatory standards.
Key Responsibilities:
- Design and develop mechanical components and systems using CAD software.
- Perform tolerance stack-up analysis and root cause analysis.
- Collaborate with R&D, manufacturing, and quality teams.
- Conduct prototyping, testing, and validation.
- Maintain design documentation and ensure compliance with ISO and FDA standards.
- Participate in design reviews and implement feedback.
- Support continuous improvement initiatives.
Qualifications:
- Bachelor’s degree in Mechanical Engineering.
- 5+ years of mechanical design experience, preferably in the medical device industry.
- Proficiency in CAD software (SolidWorks or similar).
- Strong knowledge of regulatory requirements (ISO 13485, FDA).
