Control Design Engineer

Job Description

Design Control & Risk Management Compliance Engineer

Location:Cambridge, UK

Hours:37 hours per week

Contract:12-month fixed term

Industry:Biopharma / Medical Devices / Combination Products

An exciting opportunity is available for a skilled Design Control & Risk Management Compliance Engineer to join a dynamic and collaborative team working on innovative drug-device combination products. This role offers the chance to contribute at a critical stage in the product lifecycle, ensuring quality and regulatory compliance from design through to commercial launch.

As a subject matter expert, you’ll lead design control and risk management processes while collaborating with cross-functional teams and external partners. Your expertise will help ensure products are developed in line with global regulatory standards and meet the highest quality and safety expectations.

Key Responsibilities

• Lead and manage design control and risk management activities across the full product lifecycle.
• Generate, maintain, and approve design control and risk documentation to support clinical and commercial activities.
• Ensure compliance with relevant internal policies and external regulations (ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR).
• Work closely with external design firms, contract manufacturers, and internal development teams.
• Provide support for design validation activities, including use-related risk assessments.
• Contribute to regulatory submission data and support internal and external audits.

Collaborative Interfaces

• Drug product and device development teams (including engineers, analysts, packaging specialists, and SMEs)
• Quality Assurance and Regulatory Affairs teams
• External designers and Contract Manufacturing Organizations (CMOs)
• Manufacturing and post-launch teams

Required Qualifications and Experience

• BSc or MSc in a science or engineering discipline (e.g., Biomedical, Mechanical, Materials, Chemical, Chemistry, Biology)
• Minimum of 5 years of experience in medical device or combination product development
• Hands-on experience with design control and risk management practices
• Proven track record of working within ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR environments
• Familiarity with human factors engineering and usability testing
• Understanding of device assembly and manufacturing processes

Technical Skills and Competencies

• Knowledge of additional standards such as ISO 9001, EN 60601, EN 62304, and EN 62366 is desirable
• Strong attention to detail and technical accuracy
• Ability to work independently and manage multiple priorities
• Strong communication and documentation skills
• Proficiency in standard office and documentation tools
• Knowledge of Good Manufacturing Practices (GMP)

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