Senior Manufacturing Engineer – 5+ YRS Automation & Process Development EXP RQD

Senior Manufacturing Engineer (Process Development & Scale-Up)

North Brunswick, NJ (On-site, full-time)

About Us

Sonder Research X is a pre-clinical biotech company advancing a proprietary liquid biopsy platform for early detection of cancer. Our mission is to provide relief to patients through accurate and convenient diagnostics, and to equip physicians with clinically meaningful tools that enhance patient outcomes. We are currently moving toward clinical validation and commercialization.

The Opportunity

Role

We are seeking a Senior Engineer to lead the critical transition of our diagnostic platform from R&D to scalable manufacturing. This is a high-impact role focused on three core strategic pillars:

• Custom Automation: Spearhead the development of a bespoke liquid handling system by serving as the key technical liaison with our OEM automation partners.
• Microfluidic Scale-Up: Mature our in-house microfluidic chip production, optimizing for materials and processes in preparation for high-volume manufacturing.
• Technology Transfer: Develop a robust process and documentation package to successfully transfer our chip manufacturing to a qualified external vendor/CMO and comply with ISO13485 requirements.
  
  
  

You will be the hands-on technical authority responsible for building the bridge between our science and a commercially viable, regulated product.

Key Responsibilities

Automated Process Development:

• OEM & Vendor Liaison: Act as the primary technical lead with OEM partners for robotic liquid handling systems. Define requirements, co-develop solutions, and validate custom automation to meet assay and production needs.
• Workflow Development: Design, optimize, and validate automated manufacturing processes for the liquid biopsy platform with emphasis on reliability, scalability, and cost-effectiveness.
• Automation System Implementation & Validation: Program, configure, and maintain automated systems (e.g., Hamilton, TECAN) to ensure readiness for regulatory validation and compliance. Act as the primary technical expert for troubleshooting, optimization, and ongoing system support (including IQ/OQ/PQ).
• Integrated Automation: Develop and implement integration strategies that connect robotics, liquid handlers, and analytical instruments into seamless, end-to-end workflows that support scale-up and sustained manufacturing.
  
  
  

Microfluidic Process Scale-Up & Technology Transfer

• Device Fabrication & Assembly: Lead the hands-on fabrication and assembly of proprietary microfluidic devices. Collaborate with vendors to co-develop custom automation equipment that consistently meets stringent quality standards.
• Manufacturing Partnerships: Identify, evaluate, and qualify high-volume manufacturing partners and contract manufacturing organizations (CMOs) to support scale-up.
• Technology Transfer: Develop and own the technology transfer process, including documentation, validation, and training to ensure seamless transition of chip manufacturing from in-house prototyping to third-party production.
• Process Ownership: Drive continuous improvement in manufacturability, yield, and reliability throughout the transfer and scale-up lifecycle.
  
  
  

Quality & Compliance

• Inspection & QC: Perform rigorous in-process inspections and final quality checks to ensure all fabricated devices meet design specifications. Maintain meticulous documentation of results.
• Validation & Regulatory Alignment: Author and execute validation protocols, test methods, and SOPs. Ensure all manufacturing processes and documentation rigorously comply with ISO 13485 and FDA QMSR (21 CFR Part 820).
  
  
  

Manufacturing Engineering & Continuous Improvement

• DFMA & Tooling: Lead design-for-manufacturability efforts to translate R&D protocols into production-ready solutions. Design and fabricate custom jigs, fixtures, and labware using CAD and 3D printing.
• System Implementation & Support: Validate, maintain, and troubleshoot automated systems (e.g., Hamilton, TECAN) to ensure reliable operation.
• Process Optimization: Lead initiatives for process efficiency, quality improvements, and risk reduction across manufacturing workflows.
  
  
  

Vendor & Partner Engagement

• Vendor Management: Collaborate with equipment vendors and material suppliers to source, install, and qualify new automation and fabrication technologies.
• External Partnerships: Build and sustain strong relationships with external partners to ensure reliable supply chains and timely implementation of new solutions.
  
  
  

Project & Team Leadership

• Budget & Planning: Track resource needs and support cost management for manufacturing projects.
• Cross-Functional Collaboration: Partner with R&D, operations, and quality teams to ensure smooth transfer of new processes into production and alignment with company objectives.
• Continuous Improvement: Lead initiatives to enhance process efficiency, quality, and reduce risk.
• Quality & Compliance: Author and execute validation protocols, test methods, and SOPs. Ensure all manufacturing processes and documentation rigorously comply with regulatory requirements, including ISO 13485 and FDA QMSR (21 CFR Part 820). Record detailed notes and observations during fabrication and present progress to the team.
  
  
  

Qualifications

• Education: Bachelor’s or Master’s degree in Engineering (Biomedical, Mechanical, Chemical, or related field).
• Experience: 5 years of hands-on experience in a manufacturing, process development, or automation engineering role within a regulated industry (medical device, diagnostics, biotech, or pharmaceuticals).
• Technical Skills:
• Required: Direct experience working in a regulated environment governed by standards such as ISO 13485 or FDA QMSR.
• Required: Hands-on expertise in programming, optimizing, and validating automated liquid handling systems (e.g., Hamilton, TECAN, Beckman).
• Required: Strong background in process validation (IQ/OQ/PQ), design for manufacturability (DFM), and root cause analysis.
• Proficiency in 2D/3D CAD software (e.g., SolidWorks, Onshape, AutoCAD, Fusion) with hands-on experience in rapid prototyping tools, including 3D printing, laser cutting, and engraving.
• Strong scripting skills, preferably in Python, for instrument control and data handling, are a plus.
• Mindset: A meticulous, hands-on problem-solver with exceptional attention to detail, capable of balancing high-level process design with the precise, practical execution of fabrication and assembly tasks. Excellent verbal and written communication skills are essential.
  
  

Performance Metrics

• Successful and timely transfer of new automated processes into manufacturing.
• Consistent and high-quality fabrication of microfluidic devices meeting all specifications.
• On-time execution of equipment and process validation (IQ/OQ/PQ) milestones.
• Measurable improvements in key production metrics (e.g., yield, cycle time, failure rates).
  
  
  

Compensation & Benefits

$95K - $140,000

Location

North Brunswick, NJ

Application Requirements: To be considered for this role, please respond to the following questions in your application. Applications without responses will not be reviewed.

What is your desired salary range for this position?

Are you able to work full-time on-site at our North Brunswick, NJ facility?

• If you are not currently living in New Jersey, are you willing to relocate?
• Will you now or in the future require Sonder Research X to sponsor a visa for employment in the United States? Sonder does not sponsor visas at this time.