ENDRA Life Sciences (ENDRA) has a unique opportunity for someone who wants to make an impact in emerging medical technology. We have developed a method and device for deep tissue thermoacoustic imaging that will directly address fundamental barriers to advancing the diagnostic value and expanding the use of conventional ultrasound imaging.
We are seeking a Systems Engineer, with knowledge of and experience in the development of complex sensor systems designed for the fast and accurate measurement of remotely-sensed phenomena within human subjects. Delivery of systems in a medical device context will require compact, cost-effective approaches, suitable for scalable production, which support device utility in compliance with regulatory requirements for safety, effectiveness and clinical environment compatibility. Specific knowledge of Optical, Radio-Frequency (RF) or Acoustic systems, and combinations thereof, will be of significant benefit.
Roles and Responsibility:
Maintain cradle-to-grave ownership for system design and performance, including user safety and customer satisfaction
Ensure compliance with medical device regulatory and risk management requirements and guidelines from domestic and international regulatory agencies
Identify and maintain product requirements
Conduct requirements flow-down, decomposition and allocation across system elements
Document work in clear, concise fashion and ensure that all designs, test plans and test reports are documented and completed in accordance with the Quality Management System
Engage with production partners to ensure design for manufacturing
Be a role model for the team in excellent engineering, while designing a medical device under regulatory controls
Communicate issues and openly identify risks; proactively engage to identify the root causes of issues and to identify viable solutions
Develop ground-breaking medical device solutions
Develop responsive design concepts at system and subsystem levels, addressing functional, operational and physical requirements for mechanical, hardware and software elements
Develop verification/validation strategies and execute them
Collaborate with Engineering Team to ensure satisfaction of functional, physical and operational requirements and compliance with all requisite standards
Collaborate on technical reviews of designs and documents; Mentor engineers within the team
Deliver on aggressive schedules, with excellent results
Education & Experience Requirements:
Bachelors or Master’s degree in BME,EE, or a similar degree in the Physical Sciences with relevant experience
7 to 10+ years’ experience in the successful engineering design, development and testing of complex systems, including mechanical, hardware and software elements
Medical device development experience, involving the application of relevant technologies
Industry experience in high power RF, ultrasound, signal and image processing, real-time data acquisition
Systems engineering experience, for example including requirements analysis, system modeling, functional safety, cybersecurity
Knowledge, Skills, Abilities:
Requisite academic and experiential credentials in relevant technical areas
Entrepreneurial spirit: ability to work in low-structure, tight-resource environment of an early stage, high-growth company.
Experience with systems engineering and development to culminate in manufacturing and delivery to end users
Willingness to travel to interact and oversee vendors and outsourced engineering/production partners
Work with a sense of urgency: delivers on development milestone commitments.
Demonstrate clear and thoughtful communication.
ENDRA’s mission is to commercialize globally accessible technologies that will transform point of care disease detection and diagnosis, and the monitoring of therapies. We focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.
ENDRA is not for everyone … hard work, exciting challenges, limited resources, highly collaborative, fast-paced, and a path toward making a significant impact in the medical device field!
Compensation is competitive with base salary, and long-term incentives tied to company success (our stock started trading on NASDAQ in May 2017).
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, age, color, religion, sex, national origin, protected veteran status, or disability status.
ENDRA Life Sciences, Inc. is a drug-free workplace.