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. Specific knowledge of Optical, Radio-Frequency (RF) and Acoustic systems, and combinations thereof, will be of significant benefit. 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.
Role and Responsibility
- Develop specifications and responsive design concepts at system and subsystem levels, addressing functional, operational and physical requirements for hardware and software elements
- Ensure compliance with safety and effectiveness requirements and guidelines from domestic international regulatory agencies
- Maintain cradle-to-grave ownership for system design and performance including user safety and satisfaction
- Maintain requirements baseline and configuration control
- Conduct requirements flow-down, decomposition and allocation across system elements
- Develop testing requirements and methodologies and verification/validation strategies and execute them
- Collaborate with Engineering Team to ensure satisfaction of system functional, physical and operational requirements and compliance with all requisite standards
- 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 in place
- Engage with production partners to ensure design for manufacturing
- Participate in trade studies
- Be a role model for the team in excellent engineering, designing a medical device under regulatory controls and in execution
- Communicate issues and openly identify risk; proactively engage to propose and implement solutions to identified problems
- Deliver on aggressive schedules, to achieve high-performance capabilities under constraint.
Education & Experience Requirements:
- Bachelors or Master’s degree in Engineering, or a similar degree in the Physical Sciences with relevant experience
- 5+ years’ experience in the successful design, development and testing of complex systems, including hardware and software elements, in medical device market involving the application of relevant technologies (RF, ultrasound, signal and image processing, real-time operation)
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. Specifically with our employees, 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!
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.