Senior IVD Systems Engineer: Risk, Validation & Regulation

Quanterix; Billerica (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Quanterix in Billerica, MA is seeking a Senior Systems Engineer to provide deep technical leadership across the full lifecycle of IVD instrument development, from design through regulatory submission.

You will own risk management artifacts, drive design control documentation, collaborate with cross-functional teams, and help ensure compliant, manufacturable systems that meet performance targets.

Qualifications

• Bachelor's or Master's degree in mechanical/electrical engineering with relevant experience.
• Progressive experience in IVD or life sciences instrument development.
• Deep knowledge of FDA 21 CFR Part 820 and ISO 13485 design control.
• Experience authoring design history files and regulatory submissions.

Responsibilities

• Lead risk management documentation (FMEA, Hazard Analysis) across the product lifecycle.
• Assess and mitigate design risks for instrument hardware, software, and interfaces.
• Support design reviews with risk-informed input across subsystems.
• Maintain DHF completeness and traceability matrices.
• Draft and revise SOPs, instructions, and ECOs per QMS requirements.

Skills

Risk management

Technical writing

Cross-functional collaboration

Problem solving

Regulatory knowledge

Python

MATLAB

Project management

Education

Bachelor's Degree in Mechanical or Electrical Engineering

Master's Degree in Mechanical or Electrical Engineering

Tools

MATLAB

Python

Design history file tools

Job description

Quanterix in Billerica, MA is seeking a Senior Systems Engineer to provide deep technical leadership across the full lifecycle of IVD instrument development, from design through regulatory submission.

You will own risk management artifacts, drive design control documentation, collaborate with cross-functional teams, and help ensure compliant, manufacturable systems that meet performance targets.