Senior Mechanical Design Engineer

Mechanical Design Leadership

Lead mechanical design and reviews, managing complex schedules and technical requirements throughout the development process.

Prototyping & Testing

Design high-fidelity prototypes to facilitate usability studies and requirements characterization.

Verification & Validation

Define comprehensive testing plans, develop custom test methods and fixtures, and lead final product mechanical verification activities.

Lifecycle Management

Support design control documentation and lead engineering change orders (ECOs) to maintain product documentation and integrity.

Manufacturing & Sustaining

Drive manufacturing transfers and partner with production teams to identify, propose, and implement continuous improvements.

Quality Compliance

Diagnose, document, and support Cala’s Quality Management System, including any NCMRs and CAPAs related to mechanical design.

Skills And Experience

• Technical Expertise: 5+ years of experience in mechanical engineering, with a strong focus on electromechanical systems and early clinical study support.
• Practical Experience: Has taken a Class II medical device all the way from initial design through FDA 510k approval and transfer to manufacturing for commercialization.
• Experience with wearables or high-touch consumer electronics design a plus.
• Manufacturing Fluency: Design for Manufacturing (DFM) mindset, including knowledge of diverse processes including: plastic injection molding, silicone molding, machining, PCB fabrication/assembly, and 3D printing.
• Experience working with Contract Manufacturing partners to smoothly transfer development activity into production environment.
• Advanced CAD: Expert-level SolidWorks skills, specifically with complex surfacing, manufacturability, and tolerancing.
• Regulatory Knowledge: Familiarity with medical device standards, such as IEC 60601-1 (safety/essential performance) and ISO 10993 (biocompatibility).
• Quality & Rigor: Demonstrated experience with medical device phase-gate development, risk analysis, design control practices, and root cause analysis.
• Analytical Skills: GD&T, proficiency in statistical analysis (such as DOE) to inform design decisions and verification results.

Education

BS in Mechanical Engineering or a related technical field.