Principal Systems Engineer - POC Devices

The Principal Systems Engineer is responsible for defining and owning the end-to-end system architecture for Nova Biomedical point‑of‑care (POC) glucose meters. This role ensures that product requirements are translated into robust, scalable, and compliant system designs that meet clinical, regulatory, and business needs, and serves as the technical authority across hardware, software, firmware, consumables, connectivity, and manufacturing interfaces. The position exists to ensure system integrity, traceability, and long‑term platform sustainability across the POC glucose portfolio.

• Define, document, and maintain the overall system architecture for Nova Biomedical POC glucose meters, ensuring alignment with product requirements, regulatory standards, and platform strategy.
• Translate user needs, clinical requirements, and regulatory inputs into clear system‑level requirements, interfaces, and design constraints.
• Lead system‑level trade studies and architectural decisions involving hardware, firmware, software, consumables, algorithms, connectivity, and manufacturing processes.
• Own system decomposition, interface definitions, and allocation of requirements to subsystems, ensuring bidirectional traceability throughout the product lifecycle.
• Serve as the technical integrator across cross‑functional teams, including R&D, Quality, Regulatory, Manufacturing, Supply Chain, and Service.
• Identify, assess, and mitigate system‑level technical risks through analysis, modeling, and verification planning.
• Support design verification, validation, and regulatory submissions by providing system rationale, architecture documentation, and technical justifications.
• Mentor and provide technical leadership to other systems and project engineers, promoting best practices in systems engineering discipline.
• Define and govern system architecture considerations for power management, wireless charging, and energy storage, ensuring safe, reliable operation across clinical, home, and manufacturing use cases.
• Lead system‑level analysis and risk mitigation strategies related to battery thermal behavior and heat dissipation, including charging scenarios, environmental extremes, and long‑term reliability to ensure patient safety and regulatory compliance.

• Minimum of 10 years of experience in systems engineering, product architecture, or technical leadership roles within regulated medical device environments.
• Demonstrated experience defining and owning system architectures for complex electromechanical and software‑driven products.
• Strong working knowledge of medical device development processes, including design controls, risk management (ISO 14971), and systems engineering standards.
• Experience working with cross‑functional teams spanning hardware, software, firmware, consumables, manufacturing, and quality disciplines.
• Proven ability to manage complex technical tradeoffs and drive architectural decisions in a fast‑paced development environment.
• Strong analytical, problem‑solving, and technical communication skills.
• Proficiency with requirements management and system documentation tools.
• Bachelor’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related technical field required.

• Prolonged periods of sitting.
• Ability to lift up to 25 lbs.
• Ability to wear PPE.
• The full list of physical requirements for this role is available upon request.

• Competitive 401(k) company match.
• Bonus program, generous PTO, and paid holidays.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA, and Westbrook, ME offices.
• Company‑subsidized cafeteria in our Waltham, MA office.

On site in our Waltham Office.

$155,000 – $190,000 / year.

Nova Biomedical takes pride in being an equal‑opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.