Sr Systems Engineer

Senior Systems Engineer
Billerica, MA
ROLE SUMMARY:

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.

WHAT YOU'LL DO:

• 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.

BASIC QUALIFICATIONS:

• 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.

PREFERRED QUALIFICATIONS:

• 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.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

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.

WHY YOU'LL LIKE WORKING WITH US:

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 cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler, PhenoImager Fusion and HT, and PhenoCode Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.

Our Commitment to Employees:

At Quanterix, our values are based on: Team, Innovation, Customer and Owner.

Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards

Innovation: Stay curious, experiment, create and change

Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments

Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.

We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day

DIVERSE & INCLUSIVE WORKPLACE:

Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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