Senior Systems Engineer (Medical Devices)

Do you have proven experience in systems engineering for medical devices? If so, we want to hear from you!

Amber Therapeutics are looking for a Senior Systems Engineer to join our dynamic team. This is a full-time hybrid role based at our new custom-built facility in Harwell, Oxfordshire. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology. We specialize in the development of cutting-edge active implantable medical devices.

Join Amber Therapeutics to help shape the future of deep brain stimulation (DBS) and pelvic health systems. You'll play a key role in developing and documenting our medical device systems – covering requirements management, risk analysis, testing, and support for academic-led clinical trials. Reporting to the Principal Systems and Risk Engineer, you'll ensure compliance with international standards while driving system integration across software, hardware, and firmware. Your primary focus will be on DBS systems, with the opportunity to contribute to wider projects as needed.

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• Define and document system architecture, design inputs and interfaces, maintaining traceability through V&V.
  
• Drive risk management activities (FMEA, FTA), keeping files up to date in line with ISO 14971.
  
• Create and maintain technical documentation (DHF), supporting audits and regulatory submissions.
  
• Manage requirements across systems and sub-systems, ensuring traceability to risks and verification activities.
  
• Support clinical trials and investigations, resolving device‑related issues and leading verification testing.
  
• Collaborate across engineering, clinical, quality and regulatory teams to ensure integration and compliance.
  
• Contribute to process improvements, staying current with evolving standards and regulations.
  

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• Engineering or related bachelor’s or master’s degree or equivalent experience.
  
• Experience in medical device development, particularly in a regulated environment.
  
• Familiarity with ISO 14971 and medical device design controls (e.g., ISO 13485, FDA QSR).
  
• Working knowledge of system‑level requirements and documentation practices.
  
• Understanding of verification and validation principles and traceability.
  

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• Experience with implantable or neurostimulation medical devices.
  
• Exposure to standards such as IEC 60601, IEC 62304, or ISO 14708.
  
• Experience with document control and requirements management tools.
  
• Experience interacting with clinical and academic partners.
  

The successful candidate will be a detail‑oriented and versatile engineer with experience in regulated medical device development. With a strong grounding in systems engineering and the medical device development lifecycle, you will bring expertise in risk management practices & tools. With a track record in producing and maintaining technical documentation to regulatory standards (ISO 13485, FDA, MDR), you will be confident in planning, executing and reporting verification activities. To thrive in this role, you'll need excellent communication skills to work effectively across technical, clinical and regulatory teams, alongside the problem‑solving ability to tackle complex, multidisciplinary challenges.

Amber Therapeutics is developing a closed‑loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber's fully implantable Picostim™ System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information.

This is a chance to be part of a ground‑breaking team creating life‑changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first pivotal trial.

In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays).

Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you!