Senior Design Assurance Engineer

SRG; Cambridge; On-site; GBP 65,000 - 90,000; Full time

Job summary

SRG Cambridge is seeking a Senior Design Assurance Engineer to join a medical device organisation focused on next-generation drug delivery devices and combination products.

You will provide design assurance across the product development lifecycle, ensuring compliance with ISO 13485, ISO 14971, and 21 CFR Part 820 while collaborating with quality, regulatory and engineering teams to bring safe, compliant products to market.

Qualifications

• Experience developing medical devices in a regulated environment.
• Strong understanding of Quality Management Systems and quality engineering principles.

Responsibilities

• 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.
• Maintain Design History Files (DHFs) to a high standard.
• Support audits and regulatory submissions with Quality and Regulatory teams.
• Assist project teams in risk-based evaluation and traceability.

Skills

Quality engineering principles

Documentation skills

Cross-functional teamwork

Stakeholder management

Verification & Validation

Design controls

Risk management

Education

Degree in Mechanical Engineering, Biomedical Engineering, or related

Job description

Shape the Future of Medical Device Innovation

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.