Sr Systems Engineer

Senior Systems Engineer

Billerica, MA

The Senior Systems Engineer will play a key role in designing, integrating, and validating complex multidisciplinary systems. This individual will apply expert technical skills and systems-level thinking to plan, execute, and deliver product development projects from concept through manufacturing-ensuring adherence to regulatory, performance, and quality standards. Working across mechanical, electrical, software, and reagent teams, the Senior Systems Engineer will define and implement architectures & designs, decompose requirements, and drive verification and validation (V&V) activities for complex instrumentation systems, including integration with OEM partners.

This role is highly cross-functional, requiring collaboration with mechanical, electrical, optical, software, and manufacturing engineering teams.

• Support system-level product development activities for medical devices and scientific instrumentation.
• Translate user needs into system requirements and ensure design traceability throughout the product lifecycle.
• Assess design feasibility, confirm product capabilities, and guide cross-functional design reviews.
• Define and maintain system architectures and documentation trees.
• Collaborate with hardware, software, and reagent teams to align design integration across subsystems.
• Manage design control deliverables and ensure Design History File (DHF) completeness.
• Lead risk management and usability engineering activities, including FMEA and Hazard Analysis.
• Provide technical oversight to OEM and manufacturing partners; resolve design and build issues.
• Participate in verification and validation planning, execution, and documentation.
• Support continuous improvement initiatives, system cost reduction, and design optimization efforts.
• Ensure all activities adhere to applicable ISO, FDA, and GMP regulations and company SOPs.

• Bachelor's or Master's degree in Systems, Electrical, Mechanical, or Computer Engineering, or a related discipline.
• 5+ years of experience in systems engineering or multidisciplinary product development.

• Strong proficiency in Python for automation, data analysis, and system control applications.
• Proven experience with system modeling, requirements management, and interface definition
  .
• Familiarity with software-hardware integration
  , version control (Git), and continuous integration tools.
• Experience with instrumentation, sensors, or control systems preferred.
• Excellent analytical, communication, and documentation skills.
• Experience with ISO and FDA design control processes, GMP guidelines, and risk-based product development.
• Experience in scientific or diagnostic instrumentation development.
• Strong background in system analysis, model-based systems engineering, and system architecture.
• Demonstrated ability to work with cross-functional technical teams through formal phase-gate processes.

Workplace:
Full time Onsite

Travel: 10-15% (to partner, internal, contract manufacturing sites)

Core Competencies:

Systems thinking, cross-functional collaboration, regulatory awareness, documentation excellence, analytical problem-solving, and ownership mindset.

Our Technology:
From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.

Akoya Biosciences, a Quanterix company, is The Spatial Biology Company-bringing tissue context to life through high-resolution, single-cell imaging. Akoya's spatial phenotyping platforms help researchers visualize and measure how…