Medical Device Design Assurance Engineer

Cambridge Consultants; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Job summary

Cambridge Consultants is seeking a Design Assurance/Design Control/Quality Engineer to join its Healthcare team in Cambridge. You will contribute to major medical technology development projects, ensuring documentation aligns with timelines and internal processes, while improving compliance with standards and regulations.

You will engage with scientists, engineers, and QA personnel, taking lead roles on internal initiatives, and helping translate regulatory requirements into testable design

Qualifications

• Degree in a scientific field or related technical discipline.
• Knowledge of medical device quality systems (e.g., MDR, ISO 13485 and FDA QMSR).
• Excellent communication skills enabling interaction with Cambridge Consultants and client organisations.
• Knowledge of testing and Good Lab Practices.

Responsibilities

• Assist across the design process from requirements capture to manufacture on medical device projects.
• Lead or support internal projects to keep processes aligned with standards and regulations.
• Research applicable product standards and translate into verifiable requirements and traceability.
• Support risk management activities per ISO 14971 and engage project members and clients as needed.

Skills

Team player

Excellent communication

Time management

Independent planning

Education

Science degree

Job description

Cambridge Consultants is seeking a Design Assurance/Design Control/Quality Engineer to join its Healthcare team in Cambridge. You will contribute to major medical technology development projects, ensuring documentation aligns with timelines and internal processes, while improving compliance with standards and regulations.

You will engage with scientists, engineers, and QA personnel, taking lead roles on internal initiatives, and helping translate regulatory requirements into testable design