Sr Process Engineer

Description

Location: Hopkinton (CDP), MA

Salary: $53.00 USD Hourly – $57.00 USD Hourly

As a Senior Process Engineer, you will play a critical role in supporting product development within the TB IDdx Automation team. You will be responsible for establishing robust manufacturing capabilities and controls, either within Revvity facilities or through external suppliers. This position requires strong technical expertise in process design, validation, and transfer to manufacturing, ensuring compliance with regulatory and quality standards.

• Provide technical input on process and production elements during new product development phases.
• Identify and address Key Technical Challenges (KTC) and Critical to Quality (CTQ) parameters early in the development cycle.
• Collaborate with suppliers to ensure robust processes and quality controls are in place.
• Ensure timely generation of design outputs to support manufacturing documentation, process setup, and validation aligned with project schedules.
• Lead design transfer activities and maintain the Device Master Record (DMR).
• Assist with process verification and validation activities, ensuring compliance with validation plans, GMP, and regulatory requirements.
• Work with partners and procurement teams to estimate manufacturing costs and align supply chain strategies.
• Implement best practices for manufacturing processes and materials selection.

• Bachelor’s degree in Engineering or Life Sciences;
  Master’s degree preferred.
• 6 years of experience in establishing and validating manufacturing processes.
• Proven track record of leading and delivering complex, cross-functional projects.
• Experience in regulated Quality Management Systems (QMS) and medical device requirements.
• Familiarity with FDA-regulated products.
• Demonstrated ability to manage external suppliers and technical partners.

• Six Sigma certification and demonstrated application of process improvement methodologies.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication and stakeholder management skills.

• Process validation and manufacturing capability development.
• Supplier engagement and quality assurance.
• Regulatory compliance (FDA, GMP).
• Cost estimation and supply chain coordination.

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