We're seeking a talented and detail-oriented Design Assurance Engineer to join an innovative Medical Device organisation based in Cambridge.
This is an exciting opportunity to play a pivotal role in the development of next-generation drug delivery devices and combination products, ensuring products are designed and developed in compliance with global regulatory requirements, industry standards, and quality expectations.
Working alongside multidisciplinary engineering, quality, and regulatory teams, you will provide design assurance expertise throughout the product development lifecycle, helping bring safe, effective, and compliant products to market.
The Role
As a Senior Design Assurance Engineer, you will be responsible for supporting product development activities while ensuring compliance with medical device regulations, design control requirements, and risk management processes.
Key Responsibilities
Design Assurance & Product Development
Support and review design control activities throughout the product development lifecycle.
Participate in risk management activities in accordance with ISO 14971.
Review engineering changes, impact assessments, and design modifications.
Ensure Design History Files (DHFs) are maintained to a high standard.
Support stage-gate reviews and provide design assurance oversight across projects.
Contribute to design decisions through technical analysis and risk-based evaluation.
Quality & Regulatory Compliance
Ensure compliance with internal Quality Management Systems and regulatory requirements.
Support internal, customer, and external audits, including ISO 13485 audits.
Collaborate with Quality and Regulatory teams on technical documentation and submissions.
Maintain awareness of evolving regulatory requirements and industry best practice.
Verification, Validation & Risk Management
Support design verification and validation activities.
Review verification evidence to ensure alignment with product requirements and risk controls.
Support test method validation and usability engineering activities.
Assist project teams in identifying and addressing compliance gaps.
Participate in risk-benefit analyses and residual risk assessments.
Documentation & Continuous Improvement
Maintain traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
Ensure documentation complies with Good Documentation Practices and company procedures.
Drive continuous improvement initiatives across design assurance processes and methodologies.
Support customer submissions involving medical device platforms and combination products.
About You
You will combine a strong quality-focused mindset with practical engineering experience gained within a regulated product development environment.
Essential Experience
Experience developing medical devices from concept through to commercialisation.
Experience working within a regulated product development environment.
Strong understanding of Quality Management Systems and quality engineering principles.
Experience supporting design control, risk management, verification, and validation activities.
Ability to work effectively within cross-functional development teams.
Excellent technical documentation and report-writing skills.
Strong stakeholder management and communication abilities.
Knowledge of
ISO 13485
ISO 14971
21 CFR Part 820
Design Controls
Risk Management
Verification & Validation
Qualifications
Degree in Mechanical Engineering, Biomedical Engineering, or a related engineering/scientific discipline.
Why Join?
This is an opportunity to work on innovative products that make a genuine difference to people's lives. You'll join a highly collaborative environment where quality, innovation, and engineering excellence are at the heart of everything the company does.
Whether you're looking to broaden your experience in Design Assurance or take the next step in your medical device career, this role offers outstanding professional development and exposure to exciting product development programmes.
Apply today to learn more about this exciting opportunity.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Salary description
£60000.00 - £70000.00 per year