Systems Engineer

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 Engineer will interact with customers, customer advocates, stakeholders, human factors and a variety of engineering disciplines to understand intended product uses, product concepts and technology. They are directly responsible for the development, review and ongoing maintenance of high quality, well understood, broadly communicated system and software requirements and are expected to develop expertise in these same areas.

ESSENTIAL DUTIES

• Lead and/or contribute to cross-functional product definition teams to define medical device systems and roadmaps.
• Lead the documentation, review, communication and maintenance of assigned areas of Requirements and associated Traceability
• Lead and/or contribute to Risk Analysis activities, as required, in assigned areas
• Work directly with engineering leads to translate System Requirements, Interaction/UI Design and System Risk Analyses into component-level requirements, designs and risk management approaches
• Perform regular System Integration and System Testing during development
• Support System and Software Verification planning, protocol development and reporting, as required
• Analyze system problems and determine root cause
• Develop and implement corrective actions

COMPETENCIES

• Ability to be a self-starter, seek new and better methods, and work with minimum supervision
• Demonstrates deep expertise in profession and industry best practices
• Ability to collaborate within a Team environment and across functions
• Embraces Kestra’s Mission & Core Values
• Capability to discern relevant facts and in turn, effectively resolve issues
• Ability to be flexible in a fast-paced goal-oriented environment
• Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win

QUALIFICATIONS

• Bachelor of Engineering Degree
• BS degree with a minimum of 3 years of related experience
• MS degree with a minimum of 1 years of related experience
• PhD degree with a minimum of 1 year of experience
• Direct experience with definition and documentation of Engineering / Technical requirements
• Excellent verbal and written documentation and communication skills in English

PREFERRED

• Systems, biomedical, software and/or electrical engineering background
• Direct, practical experience with IEC 62304-compliant SW Development and Agile development methods.
• Experience with medical device development with significant software content.
• Familiarity with mobile platforms (iOS, Android)
• Experience with medical device risk analysis, ISO 14971 and/or IEC/TR 80002-1
• Experience with requirements management and traceability tools
• Passion for defining and delivering high-quality products that satisfy users’ needs
• Ability to invent, think creatively, and be resourceful

SUPERVISORY RESPONSIBILITES

• None

WORKING CONDITIONS

• Fast paced office environment
• Lab environment
• Noise level typical of an open office environment
• Extended hours, as needed

PHYSICAL DEMANDS

• Frequent keyboard and mouse usage
• Frequent sitting for extended periods of time
• Occasional bending and stooping
• Occasional lifting up to 20 pounds

TRAVEL

• Occasional travel, less than 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 offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.

Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.

Salary: Annualized at $100,000 - $120,000, plus bonus. Depending on experience.

Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, age, sexual orientation, gender identity and/or expression, marital status, disability, physical or mental status or any other characteristic protected by law.

We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.

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.