Quanterix

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognosis and precise 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, including oncology, neurology, cardiology, inflammation and infectious disease.

We are looking for an experienced and highly motivated Process Engineer to join our Accelerator Team located in Billerica, MA . The successful candidate will play a crucial role in ensuring the robust transfer of Laboratory Developed Tests (LDT) and In Vitro Diagnostic (IVD) assays from the Accelerator team to pilot/manufacturing team prior to regulatory submission, which includes performing the necessary tasks to complete a Design Control project. This position requires a strong understanding of both immunoassay development and manufacturing processes, with a focus on maintaining assay integrity, optimizing efficiency, and ensuring regulatory compliance. 

What You’ll Do:

• Process Development and Optimization:
• Drive new product introductions (NPI) to manufacturing through assessment of raw materials, drafting of work instructions, and manufacture of pilot scale assay reagents
• Collaborate with R&D and manufacturing teams to understand assay requirements and design specifications.
• Develop and optimize processes for the efficient and reproducible transfer of assays from Accelerator to manufacturing.
• Technical Transfer:
• Work closely with the Project Management and Scheduler to review manufacturing requirements and generate build plans, establish priorities, resolve problems, and report results
• Lead the technical transfer of LDT/IVD assays to pilot/manufacturing, including documentation, training, and troubleshooting.
• Develop detailed process transfer protocols, standard operating procedures (SOPs), and batch records.
• Perform batch record reviews for manufacturing records, complete/review Syteline ERP transactions for associated job orders
• Participate in inventory control and replenishment, interfacing with area managers and other manufacturing technicians
• Plan and execute process validation and verification activities to demonstrate the robustness and reproducibility of transferred assays
• Continuous Improvement:
• Drive lean manufacturing efforts, process improvements, regulatory compliance & quality improvement projects, cost reduction efforts, capacity planning, organizational development and supply chain initiatives to enhance efficiency, yield and quality
• Participate in documentation, design reviews, risk assessments and other process improvements, investigations and resolutions of product/process issues
• Stay updated with industry trends and technological advancements to incorporate best practices into process development and transfer
• Documentation and Compliance:
• Initiate, investigate & close quality systems (deviation, NCMR, CAPA, change control)
• Ensure all process documentation is accurate, complete, and compliant with regulatory standards (e.g., FDA, ISO).
• Maintain detailed records of all process development and transfer activities.
• Support regulatory submissions and inspections, as required.

What We’ll Expect From You: 

Basic Qualifications:

• MS degree in Engineering, Biotechnology, Biochemistry or related field; or BS with relevant experience
• Proven experience in process engineering, preferably within the LDT/IVD or medical device industry.
• Demonstrated experience with successful medical device manufacturing transfer to support regulatory submission (21 CFR 820).
• Experience with process validation, statistical analysis, and continuous improvement methodologies.
• Demonstrated ability to Transfer Design to support new product launches.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
• Knowledge of regulatory requirements and standards (e.g., FDA, ISO 13485, ISO 14971) is highly desirable.

Preferred Qualifications:

• 5+ years of experience transferring medical devices to manufacturing is preferred
• Previous experience with automation and high-throughput screening
• Familiar with electronic document management systems, i.e. MasterControl, Arena
• Familiar with CLSI Guidelines
• Proficiency in statistical software (e.g. JMP, Minitab)

Expectations, Skills & Abilities:

• This position is on-site

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 drinks every day!

Quanterix is committed to a Diverse and Inclusive workplace. 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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