Head of Hardware Engineering

Readout Health is changing the way we prevent, treat, and reverse cardiometabolic disease. We are a social impact breath biomarker company that launched Biosense in the consumer and clinical space to drive behavior modification with fat oxidation data, coaching, and digital therapeutic solutions.

At Readout, we are passionate about designing, developing, and delivering a world class solution around this technology to provide users and medical professionals the critical decision-making test results they need for improved patient outcomes. 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 while imporoving the societal obesity epidemic.

Primary Function:
As a Head of Hardware Engineering, you will be responsible for leading the
electro-mechanical hardware and firmware engineering for the Biosense® FDA Class 1 handheld medical device.

The Head of Hardware Engineering is accountable for ensuring engineering best practices and quality systems are followed from product design through implementation to high-volume manufacturing. The candidate must be willing to perform engineering duties including generating electrical hardware documents, 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 lead internal and third-party design and manufacturing partners for new and revised products, while ensuring engineering requirements are met. 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 & Responsibilities:
• Develop concepts and design hardware for next generation product requirements to add functionality, improve performance and reduce cost.
• Identify and execute on design and process improvement opportunities.
• Ensure engineering standards and best practices are followed including medical device standards 21 CFR820 and ISO 13485, and product lifecycle anagmment.
• Performs system-level, board-level or component-level analysis.
• Characterize unit-to-unit variability due to manufacturing tolerances as well as environmental conditions and potential mechanical changes throughout useful life.
• Develop robust, well-documented and quantified control schemes to ensure system performance metrics are met throughout range of permitted variability.
• Lead root cause investigations into device quality issues, including designing experiments, analyzing data, and implementing hardware/firmware updates and corrective actions.
• Design and development of test systems required for verification; performs risk management evaluations and executes test protocols for system verification.
• Manage the transfer of hardware, firmware and process changes to manufacturing.
• Support manufacturing to plan and execute improvements for Manufacturability and Testability. Support production issues as required.
• Ensures Quality Assurance has been performed & approved.

Skills & Experiences:
• BSE (or equivalent) from an accredited university in electrical engineering or similar, MSE desired.
• 8+ years of experience in electrical design, with demonstrated success leading projects through to a robust, verified, producible design to volume production on time and at cost.
• Experience in all phases of the product development lifecycle including feasibility, design, development and transfer to production.
• Knowledge of, and experience with implementing and maintaining compliance with Medical Device standards including IEC 60601, IEC 62304, IEC 62366, ISO 13485, etc.
• 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.
• Strong knowledge and experience of PCB testing and documentation (schematics, PCB fabrication & assembly drawings, etc.)
• Familiarity and working experience with electrical embedded systems, firmware and software design and development is a plus.
• Effective communication skills and ability to lead a multidisciplinary team.

Readouf Health is an equal opportunity employer and urges diverse applicants to apply. We do not accept third party applications.