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Kestra Medical is a medical device company founded in 2014 that combines wearable technologies with proven cardiac device therapies. The company has over 400 years of collective experience in external and internal cardiac medical device markets and is focused on helping patients and care teams monitor, manage, and protect life through innovative, patient-centric solutions.
The Systems Engineering Manager role is responsible for leading the execution of strategic product development objectives by providing both technical leadership and direct systems engineering contributions across the full product development lifecycle. This is a hands-on management position where you will lead a small team of Systems Engineers while actively participating in system architecture, requirements development, risk management, system integration, and verification activities.
Key responsibilities include:
• Leading and developing the Systems Engineering team, including performance reviews, feedback, goal-setting, resource allocation, and career development support
• Generating and analyzing system architectures, requirements, and risk management artifacts
• Communicating and coordinating with cross-functional teams to translate customer, clinical, business, and regulatory requirements into robust medical device solutions
• Providing technical leadership for system integration, verification, validation, and problem resolution
• Advising teams on systems engineering tools, methods, and standards
• Monitoring work to ensure technical quality, effective execution, and schedule adherence
• Continuously improving systems engineering processes, tools, and best practices
The role requires strong collaboration across engineering, product, clinical, and regulatory functions. You will work in an indoor open office environment with occasional travel (approximately 10%). Extended hours may be required when needed.
QUALIFICATIONS:
Required:
• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Software Engineering, or related discipline
• Minimum 10 years of relevant experience
• Demonstrated experience leading cross-functional engineering teams
• Direct experience with requirements development, traceability management, risk management, system architecture, and verification activities
• Strong written and verbal communication skills
Preferred:
• Previous people management experience
• Direct experience developing regulated medical devices
• Strong knowledge of ISO 14971, IEC 60601 series, IEC 62304, IEC 62366, and FDA design control requirements
• Experience with requirements management and traceability tools such as IBM DOORS
• Experience supporting FDA, EU MDR, and international regulatory submissions
