Engineer (Mechanical Design)
About The Position
This role involves owning the top-level assembly model of the entire product to ensure the creation of reliable, manufacturable, and compliant incisionless surgery products that meet performance and regulatory standards. The engineer will develop 3D CAD models, detailed drawings, and assemblies, ensuring design intent aligns with functional requirements. This position requires collaboration with mechanical and electrical engineers for subsystem integration, overseeing prototype fabrication and assembly suppliers, and building prototype assemblies for manufacturing transfer. The role also includes optimizing designs with suppliers and manufacturing engineers for cost-effective production and quality compliance, ensuring design documentation meets internal standards and regulatory design control requirements, and guiding junior designers and engineers. Additionally, the engineer will support verification and validation testing, including fixture design and test execution, and contribute to the continuous improvement of design standards, CAD libraries, and engineering processes. The position also includes acting as a Solidworks CAD administrator.
Requirements
- 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.
Nice To Haves
- 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.
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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
