Design Assurance Engineer

Location: Cambridgeshire

About the Role

We are looking for a talented and detail-focused Design Assurance Engineer to join a Medical Device company n Cambridge.

This is an exciting opportunity to play a key role in the development of innovative medical devices, ensuring that products are developed in compliance with global regulatory requirements, industry standards, and quality expectations.

Working across multidisciplinary project teams, you will provide design assurance expertise throughout the product development lifecycle, supporting the creation of safe, effective, and compliant drug delivery devices and combination products.

Key Responsibilities

Design Assurance & Development Oversight

Support and review design control and risk management activities throughout product development.
Ensure compliance with regulatory requirements and quality standards across development projects.
Contribute to design decision-making through data analysis and risk assessment.
Support engineering change reviews, impact assessments, and design change activities.
Ensure Design History Files (DHFs) are maintained to a high standard.
Participate in stage-gate reviews and provide cross-project design assurance oversight.

Quality & Regulatory Compliance

Collaborate with Quality teams to maintain compliance with company procedures and regulatory requirements.
Participate in internal, customer, and external audits, including ISO 13485 audits.
Maintain awareness of evolving regulations, guidance documents, and industry best practices.
Support the preparation of technical and regulatory documentation for customer and regulatory submissions.

Verification, Validation & Risk Management

Ensure verification and validation activities align with product requirements and risk controls.
Support Design Verification, Test Method Validation, and usability activities.
Assist teams in identifying and addressing compliance gaps within development programmes.
Support risk-benefit evaluations 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 improvements to design assurance processes, templates, and methodologies.
Work closely with customers to support regulatory submissions involving company device platforms.

About You

We're looking for someone who combines a strong quality mindset with practical engineering experience and excellent communication skills.

Essential Skills & 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 compliance principles.
Knowledge of medical device regulations and standards, including:
ISO 13485
ISO 14971
21 CFR Part 820
Experience supporting design control, risk management, verification, and validation activities.
Ability to work effectively across multiple projects and cross-functional teams.
Strong technical writing, documentation, and communication skills.

Qualifications

Degree (or equivalent) in:
Mechanical Engineering
Biomedical Engineering
Or a related engineering/scientific discipline

Personal Attributes

Strong attention to detail and commitment to quality.
Proactive and solutions-focused approach.
Continuous improvement mindset.
Ability to balance regulatory compliance with practical engineering solutions.
Excellent stakeholder management and communication skills.
Comfortable working directly with customers and external partners.

Guidant, Carbon
60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy