Senior Electrical 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 a Senior Electrical Engineer, you will be responsible for the electrical hardware and firmware design of the CoagCare System 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 generating electrical hardware requirements, electrical system design, electronic circuit and firmware design, developing test requirements and test procedures as well as computer-based simulation and data acquisition. You will also work with internal and third-party design and manufacturing partners to produce the final design products with quality and at scale. The ideal candidate is a self-motivated, fast-paced engineer who has a passion for learning, getting to the root of complex technical problems and producing robust, high-quality system designs.

Roles and Responsibilities:

• Develop and document designs in compliance with Quality System, regulatory requirements and applicable standards that address Marketing requirements and project needs ie 21 CFR820 and ISO 1348:2016.
• Provide guidance and understanding to navigate complex product certifications and industry regulations to include CE, UL, IEC,ISO 13485, 21 CFR 820 and ISO-14971:2019.
• Work with contract manufacturers to plan and execute design optimization for Manufacturability and Testability.
• Performs system-level, board-level or component-level analysis.
• Understand and utilize failure modes and effects analysis (FMEA), power budget, thermal budget, and design margins.
• Characterize unit-to-unit variability due to manufacturing tolerances as well as environmental conditions and potential mechanical changes throughout use life. Develop robust, well-documented and quantified control schemes to ensure system performance metrics are met throughout range of permitted variability.
• Collaborate with hardware and software development engineers to deploy optimal control schemes based on this system characterization.
• Develop concepts for next generation designs to add functionality, improve performance and reduce cost.
• Design and development of test systems required for verification.
• Develop and execute test protocols for system verification.
• Identify, document and execute on design and process improvement opportunities.
• Support production builds and equipment / systems as required.

Skills and Experiences:

• BSEE (or equivalent) from an accredited university, MSEE desired.
• 8+ years of experience in electrical design, with demonstrated success carrying projects through to a robust, verified, producible design and volume production on time and at cost.
• Familiarity with electrical safety compliance and testing, including IEC 60601.
• The ability to efficiently analyze and resolve complex electro-mechanical technical issues and evaluate tradeoffs to resolve technical problems and achieve overall project objectives.
• Understanding of manufacturing tolerances and specified performance variability for mechanical and electrical components.
• Experience in all phases of the product development lifecycle including feasibility, design, V&V and transfer to production.
• Strong knowledge and experience of PCB fabrication as well as formal PCBA documentation (schematics, PCB fabrication drawings, PCB assembly drawings.)
• Familiarity and working experience with electrical embedded systems, firmware and software design and development is a plus.
• Effective communication skills and ability to work cooperatively within a multidisciplinary team.