Process Engineer

Role Summary

The Process Engineer is responsible for the validation, engineering support and continuous improvement of manufacturing processes as well as product in our Cambridge, United Kingdom offices. You must live in this territory and position will be on site Monday - Friday.

This role requires a mechanical engineering background with hands-on quality system experience, supporting day-to-day production activities while ensuring compliance with ISO 13485, applicable regulatory and internal QMS requirements.

The Process Engineer works cross-functionally with Quality Control, Operations and QARA to ensure robust manufacturing processes, effective nonconformance management, and safe, compliant product release.

Key Responsibilities

1. Day-to-Day Quality Support for Production

• Provide daily quality engineering support to manufacturing operations
• Ensure production activities comply with:
• Approved procedures and work instructions
• ISO 13485 and other applicable requirements
• Support line readiness, start-up, and troubleshooting
• Participate in production reviews, deviation assessments, and batch disposition support

1. Design Changes & Product Improvements

• Coordinate and support design changes, design improvements, and process optimisations.
• Act as engineering representative for Design Change reviews and risk impact assessments.
• Ensure appropriate linkage between Design changes, Manufacturing process updates and Validation and verification activities.
• Support design transfer and continuous improvement initiatives

1. Manufacturing Process Validation & Control

• Lead and execute manufacturing process validation activities, including IQ/OQ/PQ for production lines and equipment
• Maintain validated state of manufacturing processes through change control and revalidation assessments
• Support transfer of validated processes into routine production

1. Nonconformance (NC) & Deviation Management

• Lead or support investigation of manufacturing-related nonconformances
• Coordinate root cause analysis using structured problem-solving tools (e.g. 5-Why, Fishbone)
• Define and support implementation of corrective and preventive actions (CAPA) related to manufacturing processes
• Interface with Quality to ensure timely closure and effectiveness verification

1. Cross-Functional Coordination

• Work closely with:
• Purchasing: support supplier quality issues related to manufacturing inputs
• QC Lab: support test method issues, failures, and investigations
• Warehouse: support material handling, traceability, and segregation of nonconforming product
• Repairs & Returns: analyse returned units and feed results into process improvements
• Technical Services: support field-reported manufacturing issues
• Provide technical and quality input for supplier-related issues impacting manufacturing

1. Documentation & Compliance

• Author and review controlled documents such as SOPs, Work Instructions, etc.
• Support internal and external audits by providing process-level evidence and explanations

Required Qualifications & Experience

Education

• Bachelor's degree in Mechanical Engineering (or equivalent engineering discipline).

Experience

• Experience in medical device or IVD manufacturing, strongly preferred or 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
• Experience supporting:
• Nonconformance investigations
• Change control and design changes
• Ability to support ISO/ MDSAP/ regulatory audits

• Structured problem-solving mindset
• Ability to work independently in a fast-paced manufacturing environment
• Comfortable interacting with Quality, Engineering, and Operations teams