Senior Mechanical Design Engineer (Medical Devices)

Location: San Mateo, California, United States

Salary: $125,000–$180,000 per year

Company

hirify.global develops non-invasive prescription neuromodulation therapies for chronic diseases, including hand tremor, with applications across neurology and cardiology.

What you will do

• Lead mechanical design activities, design reviews, schedules, and technical requirements throughout product development.
• Design high-fidelity prototypes for usability studies and requirements characterization.
• Define testing plans, develop custom test methods and fixtures, and lead mechanical verification and validation.
• Maintain design control documentation and lead engineering change orders.
• Drive manufacturing transfers and collaborate with production and contract manufacturing partners on continuous improvements.
• Support the Quality Management System, including investigations related to nonconformances and corrective and preventive actions.

Requirements

• Bachelor’s degree in Mechanical Engineering or a related technical field.
• 5+ years of mechanical engineering experience focused on electromechanical systems and early clinical study support.
• Experience taking a Class II medical device from initial design through FDA 510(k) approval and manufacturing commercialization.
• Expert-level SolidWorks skills, including complex surfacing, manufacturability, and tolerancing.
• Knowledge of design for manufacturing, medical device standards such as IEC 60601-1 and ISO 10993, design controls, risk analysis, and root cause analysis.
• Must be authorized to work full-time in the United States or eligible for a sponsorship path supported by hirify.global.

Nice to have

• Experience designing wearables or high-touch consumer electronics.
• Experience with plastic injection molding, silicone molding, machining, PCB fabrication and assembly, and 3D printing.
• Experience with statistical analysis methods such as DOE and with GD&T.

Culture & Benefits

• Fast-paced startup environment focused on developing medical devices for chronic disease treatment.
• Benefits package with compensation adjusted based on experience, skills, market benchmarks, internal equity, and candidate location.
• Tools, training, and mentoring are provided to support employee development.
• Commitment to diversity and selection based on role requirements.