Process Engineer

ASSOCIATE PROCESS ENGINEER II

Job ID: 171-1812

Billerica, MA

Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are 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.

To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.

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:

• Bachelor's degree in Engineering, Biotechnology or Biochemistry with 2+years of experience in Process Engineering OR a Master's degree in Engineering, Biotechnology or Biochemistry with 0-2 years of process engineering experience.
• Experience in process engineering within the LDT/IVD or medical device industry.

PREFERRED QUALIFICATIONS:

• 5+ years of experience transferring medical devices to manufacturing is preferred
• Demonstrated experience with successful medical device manufacturing transfer to support regulatory submission (21 CFR 820).
• Demonstrated ability to Transfer Design to support new product launches.
• Previous experience with automation and high-throughput screening
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
• Experience with process validation, statistical analysis, and continuous improvement methodologies.
• Familiar with electronic document management systems, i.e. MasterControl, Arena
• Familiar with CLSI Guidelines
• Proficiency in statistical software (e.g. JMP, Minitab)
• Knowledge of regulatory requirements and standards (e.g., FDA, ISO 13485, ISO 14971) is highly desirable.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES

• This position is on-site

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.

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