Principal Systems Engineer
1 day ago
Cala Health is a pioneering company working to revolutionize the treatment of chronic disease. Our mission is to empower people to take control of their health and live life to the fullest.
The OpportunityWe are seeking a highly skilled Principal Systems Engineer to join our product development team. As a key member of our team, you will be responsible for leading the system engineering of our commercial products, including new development efforts and feature updates to our flagship product, Cala kIQ.
As a Principal Systems Engineer, you will be responsible for the entire design life cycle, from creating technical requirements to ensuring that the overall design of the system and its components meet those requirements. You will work closely with our hardware engineering disciplines, manage the design verification testing process, and create technical documentation to support our medical device quality system and regulatory submissions.
Key Responsibilities- 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 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.
- 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 as IEC and FCC/PTCRB on several medical device development programs.
- 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.
Cala Health believes our success is based on diversity of people, teams, and thinking. We offer all employees the tools, training, and mentoring they need to succeed.
Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race, or any other legally protected classification.
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