Responsibilities
Own the top level assembly model of the entire product to enable creation of reliable, manufacturable, and compliant incisionless surgery products that meet the required performance and regulatory standards.
- Responsible for the top level assembly model of the entire product.
- Develop 3D CAD models, detailed drawings, and assemblies while ensuring design intent aligns with functional requirements.
- Partner with mechanical and electrical engineers to integrate subsystems into cohesive designs.
- Oversee prototype fabrication and assembly suppliers.
- Build prototype assemblies in preparation for transfer to manufacturing
- Collaborate with suppliers and manufacturing engineers to optimize designs for cost-effective production and quality compliance.
- Ensure design documentation meets internal standards and regulatory design control requirements.
- Guide junior designers and engineers, mentoring in best practices for mechanical design, modeling, and documentation.
- Support verification and validation testing activities, including fixture design and test execution.
- Contribute to continuous improvement of design standards, CAD libraries, and engineering processes.
- Solidworks CAD administrator.
Job Qualifications.
Minimum qualifications:
- Bachelor’s degree in Mechanical Engineering field or similar.
- 8+ years of experience in mechanical design, with at least 4 years in capital equipment or medical device systems.
- Strong proficiency in 3D CAD platforms (e.g., SolidWorks, Creo, or NX) and PLM systems for design control management.
- Established track record in designing complex electromechanical systems.
- Proven understanding of materials, manufacturing processes, and part tolerancing principles.
- Familiarity with regulatory and quality system requirements for medical devices.
- Excellent communication skills and ability to collaborate effectively with cross-disciplinary teams.
- Strong mechanical assembly problem-solving skills with hands-on prototyping experience.
Preferred qualifications:
- 15+ years of experience in mechanical design, with at least 10 years in capital equipment or medical device systems.
- Experience designing mobile cart medical devices.
- Working knowledge of design for reliability, FEA, and tolerance stack-up analysis.
- Practical experience in supplier development and design transfer.
Level: Senior.