Manager, Systems Engineering

QUALIFICATIONS

• Education/Experience Required:
• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Software Engineering, or a related discipline with a minimum of 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.
• SUPERVISORY RESPONSIBILITIES:
• Directly supervise Systems Engineering team members including conducting performance reviews, providing performance feedback, establishing development goals, allocating resources, and supporting career growth.
• WORK ENVIRONMENT
• Indoor open office environment
• Minimal noise volume typical to an office environment
• Extended hours when needed
• Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment post-offer.
• PHYSICAL DEMANDS
• Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
• Frequent stationary position, often standing or sitting for prolonged periods of time
• Frequent computer use
• Frequent phone and other business machine use
• Occasional lifting required, typically between 2-15 pounds
• TRAVEL
• Occasional travel may be required, 10%
• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.
• Kestra Medical Technologies, Inc does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.