Senior Mechanical Design Engineer (Medical Devices)

Location: San Mateo, California, United States; full-time work authorization in the United States is required, with sponsorship potentially available on an individual basis.

Company

hirify.global develops non-invasive prescription neuromodulation therapies for chronic conditions, including the Cala kIQ therapy for hand tremor.

What you will do

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

Requirements

• 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, manufacturing transfer, and commercialization.
• Expert SolidWorks skills, including complex surfacing, manufacturability, and tolerancing.
• Design for Manufacturing experience with injection molding, silicone molding, machining, PCB fabrication and assembly, and 3D printing.
• Knowledge of medical-device standards including IEC 60601-1 and ISO 10993, as well as phase-gate development, risk analysis, design controls, and root cause analysis.
• Proficiency in GD&T and statistical analysis methods such as DOE; BS in Mechanical Engineering or a related technical field.

Nice to have

• Experience designing wearables or high-touch consumer electronics.

Culture & Benefits

• Startup environment with a focus on diversity of people, teams, and thinking.
• Tools, training, and mentoring are provided to support employee development.
• Selection is based on role requirements and commitment to a non-discriminatory process.