About Cala Health

Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. Cala Health’s lead product, Cala Trio™, is the only non-invasive prescription therapy for essential tremor and is now available through a unique digital business model of directto-patient solutions. New therapies are under development in neurology, cardiology, and psychiatry. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, visit CalaHealth.com.

The Opportunity
Cala Health is seeking a Quality Engineer to join our growing team. The role will report to Director, Quality, Regulatory & Compliance.

Specific Responsibilities also include

• Develop new processes to align with regulatory requirements.
• Work with manufacturing to streamline and improve processes
• Manage and implement failure analysis process and report writing.
• Develop test and inspection methods
• Support product development and verification activity throughout each phase
• Support and recommend product design improvements
• Update and maintain risk documentation and other design documentation
• Support maintenance of quality records including document change orders, nonconforming material review, and CAPAs
• Support company goals and objectives, policies and procedures, the Quality System Regulation, ISO/MDD regulations, and other regulatory requirements

Desired Skills and Experience

We are looking for an engineer to support Quality in a dynamic, fast-paced startup environment, exemplified by:

• BS or MS Engineering degree or equivalent
• Minimum 3 years work experience, preferably in a technical capacity and/or in a medical device company
• Flexibility in working in a fast pace, dynamic environment
• Works independently with minimum oversight
• Strong computer skills and experience, including Microsoft Office products
  
• Strong interpersonal, analytic and organizational skills
  
• Process orientation when planning and performing work
  
• Ability to understand and interpret written material as well as explain those materials to team members and employees
  
• Good writing and communication skills

If you or someone you know might be interested in this position, please submit a resume & an introductory email to careers@calahealth.com.

Please click here to see online flyer.