NOTA Labs, a lifesaving startup based in Ann Arbor, MI, is focused on developing affordable Nitric Oxide (NO) delivery systems for hospital and in-home use. NO has broad utility for treating many debilitating and potentially life-threatening conditions and diseases, including a wide range of respiratory infections such as pneumonia and bronchiolitis. It is also used to treat neonates born with underdeveloped lungs and prevents reperfusion injury that is common in open-heart surgery.  In fact, it has multiple functions in the body including anticlotting, antimicrobial, vasodilation and anti-inflammatory.
 
We are growing and are currently seeking a Senior Electronics Engineer to join our team comprised of highly motivated scientists, engineers, respected academic researchers, physicians, and seasoned business executives in building life-changing solutions in healthcare. The Senior Electronics Engineer provides expertise in the development, characterization and testing of control software and hardware in medical devices. They develop complex hardware and systems that include controls, motor control, sensors, pump drivers, optimize hardware and system performance, and troubleshoot hardware and system issues.
 
Location: Ann Arbor, MI (on-site)
 
Key Responsibilities:
 

• The Electronic Engineer is responsible for full life cycle development and maintenance of medical devices from concept through post-market surveillance.
• Supports new design of electronics and modifies existing designs to improve products and facilitate manufacturing operations.
• Support product activities that include contributing to manufacturing transfers and investigations, supplier-driven design changes and product enhancements, product design documentation, and conducting laboratory studies of product performance in support of product development.
• Work is conducted in compliance with applicable regulations, such as:
  • ISO 13485
  • 21 CFR 820
  • ISO 14971
  • IEC 62304
  • ISO 60601
• Recommends alterations to development and design to improve the quality of products and/or procedures.
• Determines budgets and timelines for assigned projects.
• Leads electrical product improvement for multifunctional project teams, as assigned by Engineering Leader, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
• Builds strong relationships with and provides electrical technical support to other functional groups such as Regulatory, Product Management, Manufacturing, Quality, Supply Chain, Service, and External Partners for assigned projects as needed.
• Supports and/or leads electrical testing and initiates testing of assigned products.
• Reports progress and status of assigned projects on a timely basis.
• Create technical documentation for products in development.
• Prepare design change documentation for products.
• Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls, and GxP compliance.
• May be required to travel to attend trade shows as well as prospective accounts.
• Architect electrical subsystems, gas delivery control, and safety control.
• Develop analog and digital circuits for a complex system that controls gas delivery, includes current sensors, motor control, environmental sensors, and gas delivery mechanisms.
• Utilizes technical expertise to contribute to the development of system architectures for respiratory devices. Uses modeling, hardware-in-the-loop simulation, and actual devices to develop, debug and test complex systems to meet the required performance.
• Develops and models complex cross-functional systems.
• Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify system solutions.
• Evaluates product performance on an ongoing basis and initiates and evaluates required changes to the design to improve and optimize performance.
• Ensures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirements.
• Maintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods. 

Skills and Experience:
 

• Degree in electrical engineering or related specialization, and 10+ years of related experience.
• Demonstrated experience designing, implementing, tuning and analyzing high-accuracy, multi-sensor control circuits and systems, including high-performance PID feedback and open-loop controls.
• Experience with mechanical design a significant plus.
• Experience with digital and analog electrical circuits.
• Proven ability to engage effectively in risk analysis including FMEA.
• Demonstrated strength in judgment, decision-making, and critical thinking.
• Excellent written and verbal communication.
• Demonstrated strength in building relationships at all levels of an organization.
• Experience in software-based electromechanical medical device development.
• Experience with statistical process control.
• Experience with electromechanical systems and related components, particularly flow controllers.
• Experience with ventilators and/or respiratory applications is a plus.
• Experience performing design of experiments.
• ISO 14971, IEC 60601, IEC 62304.
• Well-versed in medical product R&D and clinical/regulatory process.  ISO 13485 & 21 CFR 820 quality management system.
• Electronic systems manufacturing process knowledge.
• Experience in the medical device industry (respiratory area a huge plus).
• Project management knowledge and effective communication experience.
• Ability to work to build or modify prototypes, products, and systems suitable for testing and/or simulation to support data collection.
• Ability to learn and assist sustaining activities including research and analysis for End-of-Life component replacement, and supply chain issues for alternative components, materials, and solutions.
• Ability to learn and assist for design verification test plans, protocols, and reports for new and existing designs with direction from Design Engineering Staff.
• Ability to learn and assist on Engineering Change Orders (ECO) including engineering documentation such as drawings and schematics, processes, tools, and design history file for assigned projects, adhering to design control procedures.
• Ability to integrate continuous improvement concepts and techniques into all aspects of your role.
• Experience in early-stage startups with an insatiable thirst to build.
• Excellent communication and time management skills with an unprecedented sense of ownership and accountability.
• US Citizen or Green Card.
• Must be able to work onsite in Ann Arbor, MI.

About NOTA Labs:
Founded in 2014, NOTA Laboratories is a startup company that started as a spinout of the University of Michigan here in Ann Arbor, MI and focused on developing novel NO delivery systems and applications that augment your own body's NO production for treating and preventing a wide variety of life-threatening illnesses and conditions.
 
NOTA has received generous funding from the US National Institutes of Health, Silicon Valley-based Pegasus Tech Ventures, and NGK/Niterra out of Japan to accelerate its products toward commercialization.
 
Come join a team of dedicated and wickedly smart people aiming to improve health care with this miracle molecule. Say yes to NO!
 
No Agencies or 3^rd party solicitations