Manager, Systems Engineering

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The Systems Engineering Manager facilitates the execution of strategic product development objectives by providing both technical leadership and direct systems engineering contributions across the product development lifecycle. This role leads a small team of Systems Engineers while actively participating in system architecture, requirements development, risk management, system integration, and verification activities. The Systems Engineering Manager partners closely with cross-functional teams to translate customer, clinical, business, and regulatory requirements into robust medical device solutions while continuously improving systems engineering processes, tools, and best practices.

ESSENTIAL DUTIES

Leads and develops the Systems Engineering team. Generates and analyzes system architectures, requirements, and risk management artifacts. Communicates and coordinates with cross-functional teams. Provides technical leadership for system integration, verification, validation, and problem resolution. Advices teams on systems engineering tools, methods, and standards. Monitors work to ensure technical quality, effective execution, and schedule adherence.

COMPETENCIES

Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous improvement. Integrity: Commitment, accountability, and dedication to the highest ethical standards. Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service. Action/Results: High energy, decisive planning, timely execution. Innovation: Generation of new ideas from original thinking. Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind. Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations.

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%

OTHER DUTIES

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. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Kestra Medical Technologies Inc.’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. #J-18808-Ljbffr Kestra Medical Technologies Inc.