Senior Product Reliability Engineer

Quanterix is a company on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are hiring a Senior Product Reliability Engineer located in Billerica, MA. 

We are seeking a highly skilled and motivated Senior Product Reliability Engineer to join our dynamic team. If you are passionate about quality, regulatory compliance, and driving continuous improvement in assay reliability, we invite you to apply and be a key contributor to our success. As a Senior Assay Reliability Engineer at Quanterix, you will play a crucial role in ensuring the reliability, quality, and regulatory compliance of our immunoassays. You will be responsible for applying your expertise in ISO 13485, FDA QSR regulations, risk management (ISO 14971), FMEA analysis, and bioassay design/manufacturing to support the development, optimization, and maintenance of our assays.

What You’ll Do:

• Work cross-functionally with R&D, Manufacturing, Quality Assurance, and Regulatory teams to ensure the highest standards of Product performance and compliance are met.
• Apply your expertise in risk management (ISO 14971) and FMEA analysis to identify and mitigate potential risks associated with assay development and manufacturing.
• Collaborate with R&D teams to design and optimize bioassays for reliability and robustness, contributing to the development of assays that meet performance and regulatory requirements.
• Support the creation and improvement of inspection methods and protocols for assay quality control, in alignment with regulatory standards and company policies.
• Monitor and analyze assay quality metrics and performance data, identifying trends and areas for improvement. Implement corrective and preventive actions as needed.
• Design and conduct experimental studies aimed at enhancing assay reliability, performance, and efficiency.
• May provide general guidance, career development and train junior support staff
• Minimal travel required.

What We’ll Expect From You: 

• BS / BA in in Chemical Engineering, Biochemical Engineering, Bioengineering, or Biology/chemistry with 7+ years of relevant experience in biotechnology or in-vitro diagnostics industries.
• MS in engineering/biology/chemistry disciplines as above, with 5+ years experience.
• PhD in engineering/biology/chemistry disciplines as above, with 2+ years experience.
• Work experience in biotech, life sciences, or pharmaceutical industries preferred.
• In-depth knowledge of ISO 13485, FDA QSR regulations, ISO 14971, and FMEA analysis is desirable.
• Strong background in bioassay design, optimization, or manufacturing processes.
• Proven experience with assay reliability improvement, statistical analysis, and quality control methodologies.
• Excellent problem-solving skills with the ability to analyze complex data sets and draw actionable conclusions.
• Effective cross-functional collaboration and communication skills.

Why You’ll Like Working For Us:

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment to Employees: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an 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 awarded Equity, and we have an 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 drin