Senior Medical Device Mechanical Design Engineer

Cala Health; San Mateo (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Cala Health is seeking a Senior Mechanical Design Engineer to drive the design and development of neuromodulation therapy devices. You will lead mechanical design projects, from prototyping to manufacturing, ensuring compliance with medical device standards. The ideal candidate has over 5 years of experience in mechanical engineering, expertise in electromechanical systems, and proficiency in SolidWorks. Join us in making a difference in chronic disease management while enjoying a supportive and diverse work environment.

Qualifications

• 5+ years of experience in mechanical engineering.
• Experience with Class II medical device design.
• Strong understanding of manufacturing processes.

Responsibilities

• Lead mechanical design and reviews.
• Design high-fidelity prototypes.
• Define comprehensive testing plans and verification activities.
• Support design control documentation and ECOs.
• Drive manufacturing transfers and continuous improvements.
• Maintain compliance with quality management systems.

Skills

Mechanical engineering

Electromechanical systems

FDA 510k approval process

Design for Manufacturing (DFM)

SolidWorks

Statistical analysis

Education

BS in Mechanical Engineering

Job description

Cala Health is seeking a Senior Mechanical Design Engineer to drive the design and development of neuromodulation therapy devices. You will lead mechanical design projects, from prototyping to manufacturing, ensuring compliance with medical device standards. The ideal candidate has over 5 years of experience in mechanical engineering, expertise in electromechanical systems, and proficiency in SolidWorks. Join us in making a difference in chronic disease management while enjoying a supportive and diverse work environment.