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Control Design Engineer

Control Design Engineer

Next Phase RecruitmentCambridge, England, United Kingdom
9 days ago
Job type
  • Temporary
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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    Control Engineer • Cambridge, England, United Kingdom