Senior Mechanical Design Engineer

📋 Description

• Lead mechanical design and reviews, managing complex schedules and technical requirements
• Design high-fidelity prototypes to facilitate usability studies and requirements characterization.
• Define comprehensive testing plans, develop custom test methods and fixtures, and lead final
• Support design control documentation and lead engineering change orders (ECOs) to maintain product
• Drive manufacturing transfers and partner with production teams to identify, propose, and implement
• Diagnose, document, and support Cala’s Quality Management System, including any NCMRs and CAPAs

🎯 Requirements

• BS in Mechanical Engineering or a related technical field
• 5+ years of experience in mechanical engineering, with a strong focus on electromechanical systems
• Has taken a Class II medical device all the way from initial design through FDA 510k approval and
• Experience with wearables or high-touch consumer electronics design a plus
• Design for Manufacturing (DFM) mindset, including knowledge of diverse processes: plastic injection
• Experience working with Contract Manufacturing partners to smoothly transfer development activity

🎁 Benefits

• Market-driven salary range of $125,000 - $180,000
• Robust benefits package