The Opportunity

Cala Health is seeking a Principal Systems Engineer to join our growing product development team. The role will lead the system engineering of Cala’s commercial products, including new development efforts as well as feature updates to Cala kIQ. The role encompasses the entire design life cycle, starting at the creation of technical requirements that drive the design of the right products, all the way through to ensuring that the overall design of the system and its various components ultimately meet those technical requirements. Throughout the entire process, the Principal Systems Engineer will constantly align the engineering output of various hardware engineering disciplines, manage the design verification testing process, and create technical documentation to support Cala’s medical device quality system and regulatory submissions.

The compensation range for this role is market driven, with a salary range of $150,000 - $190,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy. 

A Day in the Life

• Manage system and subsystem requirements across mechanical, electrical, firmware, and full-stack software functions.
• Guide subsystem teams through tradeoff decisions (balancing patient and business benefit with technical complexity, schedule risk, and other factors).
• Drive the engineering risk management processes and assessments.
• Collaborate with product marketing, quality assurance, engineers, and others to specify crisp, clear and testable product requirements.
• Drive engineering, integration and design verification testing (DVT) plans/protocols, test methods, supporting evidence, and quality system reports.
• Lead internal and external lab testing activities (including IEC-60601-1 testing).
• Develop, manage, and maintain design history files and related deliverables.
• Support cross-functional design transfer process to ensure product designs are manufacturable and sustainable.
• Advise and mentor teammates on systems engineering and medical device design controls and development methodologies.
• Maintain up-to-date knowledge of medical device regulation, standards, and technologies applicable to Cala’s products.

Skills and Experience

• BS or MS Electrical Engineering with cross-discipline (Mechanical/Firmware/Software) skills and experience
• 10+ year proven track record of taking connected medical devices from concept to market
• Proven track record of success as the responsible engineer for creating test plans/reports, executing testing and meeting standards and certifications such sa IEC-60601-1 and FCC/PTCRB on several medical device development programs.
• On multiple different occasions was the primary engineer responsible for the successful testing of medical devices and the creation of associated test plans and reports for devices designed to adhere to the standard IEC-60601-1 and are subject to FCC/PTCRB certification.
• Deep experience with quality management systems (QMS), including design documentation control (ECO/DCO/MCO), and the phase-gated medical device development structure.
• Experience with PCB design software (Altium preferred).
• Experience with implementing and using requirements management software such as JAMA.
• Excellent team dynamic, person-to-person communication, and technical writing abilities.

Related jobs