ENDRA Life Sciences (ENDRA) has a unique opportunity for someone who wants to make an impact in emerging medical technologies. 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. Your leadership experience developing software for commercial products will be invaluable as you will be designing, implementing, maintaining, and documenting software for medical products.
You will own the software design process, from the initial concept stage through to a complete release to manufacturing. Research, design, and develop software systems for innovative regulated medical devices.
Essential Duties and Responsibilities
include the following. Other duties may be assigned.
Develops and analyzes software requirements to determine feasibility of design within time and cost constraints.
Consults with hardware engineers and other engineering staff to evaluate interface between hardware and software, and operational and performance requirements of overall system.
Works with internal and external partners to develop and manage the embedded software development in medical devices.
Generate software requirements and verification protocols based on product requirements.
Working with cross-functional teams, transfer designs to outsourced manufacturing partners.
Generate development record complying with medical device software regulatory requirement.
Formulates and designs software system, using scientific analysis and mathematical models to predict and measure outcome and consequences of design.
Develops and directs software system testing procedures, programming, and documentation.
Consults with reference sites and customers concerning maintenance and troubleshooting of systems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• A minimum of 3 years of experience developing software for commercial products is required, with experience developing firmware in a highly-regulated industry, with a strong preference for medical devices.
• Previous experience in a Software Lead or Senior Software position is required.
• Bachelors or Masters in Computer Science/Engineering, Computer Programming, or Physics is preferred, or an equivalent combination of education and experience may be considered.
• Experience working within a Medical Quality Management System (e.g. ISO13485, IEC60601-1, IEC62304) is preferred
- Familiarity with programming Linux operating systems with the Go language and/or with programming Intel FPGA fabrics with Verilog is an asset.
• Experience in Fault Tolerance and Design for Testing is preferred.
• Highly organized style, with ability to prioritize responsibilities and be highly flexible in a demanding product development environment.
• Effective verbal and written communication skills in English.
• Eligibility to work in the United States.
Endra Life Sciences offers:
• The opportunity to work on cutting edge technology
• Satisfaction of helping others through medical device technology
• An organization with strong core values
• A team oriented/collaborative environment
• Competitive compensation
• Excellent benefits package