Senior Mechanical Design Engineer

The role

You will lead mechanical design, prototyping, and testing for neuromodulation therapy devices. You will work on projects from early-stage prototyping through manufacturing at scale.

What you will do

• Lead mechanical design and reviews, managing complex schedules and technical requirements.
• Design high-fidelity prototypes for usability studies and requirements characterization.
• Define testing plans, develop custom test methods and fixtures, and lead mechanical verification.
• Support design control documentation and lead engineering change orders.
• Drive manufacturing transfers and partner with production teams for continuous improvements.
• Diagnose, document, and support the Quality Management System, including NCMRs and CAPAs.

Required qualifications

• BS in Mechanical Engineering or a related technical field.
• 5+ years of experience in mechanical engineering.
• Strong focus on electromechanical systems and early clinical study support.
• Has taken a Class II medical device from initial design through FDA 510k approval and transfer to manufacturing.
• Knowledge of plastic injection molding, silicone molding, machining, PCB fabrication/assembly, and 3D printing.
• Experience working with Contract Manufacturing partners.
• Expert-level SolidWorks skills, specifically with complex surfacing, manufacturability, and tolerancing.
• Familiarity with medical device standards, such as IEC 60601-1 and ISO 10993.
• Experience with medical device phase-gate development, risk analysis, design control practices, and root cause analysis.
• GD&T.
• Proficiency in statistical analysis (such as DOE).

Nice to have

• Experience with wearables or high-touch consumer electronics design

Benefits

• Robust benefits package

Before you apply

• Must be authorized to work in the United States on a full-time basis, or eligible for work authorization through a sponsorship path that Cala Health is able to support.
• Sponsorship decisions are made individually and are not guaranteed.
• Cala does not permit the use of AI during interviews and technical testing.

About the company

Cala is working to free people from the burden of chronic disease. They created the first non-invasive prescription therapy for hand tremor.