Overview
On Site
USD 53.00 - 57.00 per hour
Contract - Independent
Skills
Mergers and Acquisitions
Process Modeling
Product Development
Documentation
DMR
Verification And Validation
Procurement
Life Sciences
Quality Management
QMS
Medical Devices
Management
Six Sigma
Process Improvement
Analytical Skill
Conflict Resolution
Problem Solving
Attention To Detail
Communication
Stakeholder Management
Manufacturing
Quality Assurance
Regulatory Compliance
GMP
Cost Estimation
Supply Chain Management
Collaboration
Privacy
Marketing
Job Details
Location: Hopkinton (CDP), MA
Salary: $53.00 USD Hourly - $57.00 USD Hourly
Description:
Job Description:
Senior Process Engineer || Hopkinton, MA || Onsite
About the Role
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.
Responsibilities
Minimum Qualifications
Preferred Qualifications
Skills
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $53.00 USD Hourly - $57.00 USD Hourly
Description:
Job Description:
Senior Process Engineer || Hopkinton, MA || Onsite
About the Role
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.
Responsibilities
- 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.
Minimum Qualifications
- 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.
Preferred Qualifications
- 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.
Skills
- Process validation and manufacturing capability development.
- Supplier engagement and quality assurance.
- Regulatory compliance (FDA, GMP).
- Cost estimation and supply chain coordination.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.