Harvard Bioscience
Process Engineer
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Process Engineer
Role Summary
The Process Engineer is responsible for the validation, engineering support, and continuous improvement of manufacturing processes, alongside product development, within our Cambridge, United Kingdom office. You must reside in this territory, and the role requires on-site presence from Monday to Friday.
This position demands a mechanical engineering background with hands-on quality system experience, ensuring compliance with ISO 13485, regulatory requirements, and internal QMS standards while supporting daily production activities.
The Process Engineer collaborates cross-functionally with Quality Control, Operations, and QARA to maintain robust manufacturing processes, manage nonconformances, and facilitate safe, compliant product release.
Key Responsibilities
Day-to-Day Quality Support for Production
- Provide daily quality engineering support to manufacturing operations
- Ensure adherence to:
- Approved procedures and work instructions
- ISO 13485 and other applicable regulatory and QMS requirements
- Support line readiness, start-up, and troubleshooting
- Participate in:
- Production reviews
- Deviation assessments
- Batch disposition support
Design Changes & Product Improvements
- Coordinate and support design changes, improvements, and process optimisations
- Act as the engineering representative for:
- Design Change reviews
- Risk impact assessments
- Ensure proper linkage between:
- Design changes
- Manufacturing process updates
- Validation and verification activities
- Support design transfer and continuous improvement initiatives
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Manufacturing Process Validation & Control
- Lead and execute manufacturing process validation activities, including:
- IQ/OQ/PQ for production lines and equipment
- Maintain the validated state of manufacturing processes through:
- Change control
- Reinvestigation and revalidation assessments
- Support transition of validated processes into routine production
Nonconformance (NC) & Deviation Management
- Lead or support investigations into manufacturing-related nonconformances
- Facilitate root cause analysis using structured tools (e.g., 5-Why, Fishbone Diagrams)
- Define and support implementation of corrective and preventive actions (CAPA)
- Collaborate with Quality teams to ensure timely closure and effectiveness verification
Cross-Functional Coordination
Collaborate closely with:
- Purchasing: Address supplier quality issues related to manufacturing inputs
- QC Lab: Support test method challenges, failures, and investigations
- Warehouse: Manage material handling, traceability, and segregation of nonconforming products
- Repairs & Returns: Analyse returned units and synthesise insights for process improvements
- Technical Services: Support field-reported manufacturing issues
- Provide technical/quality input for manufacturing-related supplier issues
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Documentation & Compliance
- Author and review controlled documents (e.g., SOPs, Work Instructions)
- Assist in internal and external audits by providing process evidence and explanations
Required Qualifications & Experience
Education
- Bachelor’s degree in Mechanical Engineering or an equivalent engineering discipline
Experience
- Strongly preferred:
- Experience in medical device or IVD manufacturing
- Exposure to EU IVDR requirements
- Hands-on experience with:
- Production support in a regulated environment
- Manufacturing process validation (IQ/OQ/PQ)
- Quality systems (ISO 13485)
- Supplier quality management
- Supporting experience in:
- Nonconformance investigations
- Change control and design changes
- Ability to prepare for ISO/MDSAP/regulatory audits
- A structured problem-solving mindset
- Comfortable working independently in a fast-paced manufacturing environment
- Collaborative with Quality, Engineering, and Operations teams
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