Principal Systems Engineer - POC Devices

Principal Systems Engineer - POC Devices Nova Biomedical - 3.4 Waltham, MA Job Details Full-time $155,000 - $190,000 a year 1 day ago Benefits Paid holidays Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance 401(k) matching Qualifications Requirements management

Full Job Description Nova Biomedical:

One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical , marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets. About the company At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity . Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health. Explore what's next with us at novabiomedical.com or aicompanies.com About the role The Principal Systems Engineer is responsible for defining and owning the end-to-end system architecture for Nova Biomedical point-of-care (POC) meters. This role ensures that product requirements are translated into robust, scalable, and compliant system designs that meet clinical, regulatory, and business needs. The position serves as the technical authority across hardware, software, firmware, consumables, connectivity, and manufacturing interfaces. The role exists to ensure system integrity, traceability, and long-term platform sustainability across the POC glucose portfolio. If you're passionate about systems engineering and want to be part of a team that is shaping the future of life sciences, we'd love to hear from you, apply today! What you'll do 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 What we are looking for in you 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. Physical Requirements for this role include: Prolonged periods of sitting Ability to lift up to 25lbs Ability to wear PPE The full list of physical requirements for this role is available upon request. Why work for Nova Biomedical Flexible Medical, Dental, & Vision Coverage Competitive 401k company match Bonus Program, Generous PTO and paid holidays Generous Tuition reimbursement 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

Work Location:

On site in our

Waltham Office Targeted Salary Range:

$155,000 - $190,000/year Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.

EEO Statement:

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.

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