Senior Software Development Engineer

Company:

Abram Scientific, Inc. is an exciting, early-stage medical diagnostic device start-up company that has a patent protected innovative technology targeted at revolutionizing the hemostasis / coagulation diagnostics market. At Abram Scientific, we are passionate about designing, developing, and delivering a world class product around this technology that will give medical professionals the critical decision-making viscoelastic test results they need for improved patient outcomes, faster. To achieve this goal, we are looking for talented professionals to join our team, specifically seeking out unique team members who are driven by challenges and are looking to have an immediate and direct impact on the success of the company.

Primary Function:

As Senior Software Development Engineer, you will be responsible for the CoagCare System software, firmware and graphical user interface development throughout the entirety of the product lifecycle - from prototype design and build by hand, to final product design and high-volume manufacturing. This includes but is not limited to developing software and firmware in embedded Linux systems using a range of programming languages from C++ to Python. The ideal candidate is a self-motivated, fast-paced developer who has a passion for learning and getting to the root of complex technical problems while also being able to produce robust, high-quality code in the face of rapidly changing requirements.

Roles and Responsibilities:

• Develop and document software and firmware in compliance with Quality System, regulatory requirements and applicable standards that address Marketing requirements and project needs.
• Design and develop embedded systems including firmware, software, user interface and algorithm development.
• Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability, and manufacturability requirements.
• Design, develop, and automate test procedures for firmware, software, integration, and systems.
• Develop software test and verification plans and protocols as well as conduct prototype testing and verification testing.
• Develop and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
• Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files
• Identify, document and execute design and process improvement opportunities.
• Support production builds and equipment / systems as required.

Skills and Experiences:

• BS degree in Software or Computer Engineering, MS degree preferred.
• Demonstrated experience in, and comfort with, all phases of the product development lifecycle including design, implementation, debug, verification, validation, and transfer to manufacturing.
• Knowledge and understanding of IEC 62304, FDA guidance for medical device development and other relevant medical device regulatory standards is preferred, 21 CFR 820, ISO 13485:2016 and ISO 14971:2019.
• Knowledge and understanding of HL7, FHIR or 11073 industry standards is preferred.
• Strong experience and knowledge with programming languages such as C++ and Python.
• Experience and knowledge with Qt (or similar) and SQL preferred.
• Knowledge of and experience with hospital IT environments is a plus.
• Understanding of communication interfaces such as USB, Ethernet, WiFi and cellular, and familiarity with network technologies such as TCP/IP and UDP is preferred.
• Effective communication skills and ability to work cooperatively within a multidisciplinary team.