Senior / Principal Systems & Risk Engineer

Are you a systems engineer with proven experience in medical device risk management? Do you have experience with requirements management systems and design traceability matrices? If so, we want to hear from you!

Amber Therapeutics is looking for an experienced systems engineer to join our dynamic team as a Senior / Principal Systems & Risk Engineer. This will initially be a hybrid role based in London, moving onsite at our custom-built facility in Harwell, Oxfordshire when it opens in Q2 2025. 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.

The Role

You will lead requirements management and the integration of risk management into the design and development of Amber’s active implantable medical devices. You will ensure the safety, efficacy, and compliance of our products by driving risk management activities, maintaining a comprehensive requirements management system, and developing a robust design traceability matrix. You will bridge cross-functional teams to align technical, clinical, and regulatory objectives, shaping the next generation of adaptive neuromodulation systems while ensuring the highest standards of quality and patient safety.

Key Responsibilities:

1. Amber’s Risk Management Lead, owning and driving the risk management process per ISO 14971 standards.
2. Develop, maintain, and oversee the execution of the Risk Management File, ensuring integration with design and development processes.
3. Identify, assess, and mitigate risks associated with the design, manufacturing, and use of active implantable devices.
4. Lead risk management activities throughout the product lifecycle, including FMEA, FTA & collaborate with cross-functional teams to ensure risk controls are implemented and verified.
5. Develop and maintain the company’s Requirements Management and Design Traceability Matrix (DTM) to ensure alignment across design, verification, and validation stages.
6. Work closely with R&D, Quality, and Regulatory teams to define and document requirements to meet technical, clinical, and regulatory expectations.
7. Ensure full traceability between product requirements, risk controls, and verification/validation activities.
8. Lead efforts to streamline and automate design traceability processes using appropriate tools.
9. Ensure compliance with global regulatory requirements, including MDR, FDA QSR, IEC 62304, and ISO 13485 & prepare documentation to support regulatory submissions and audits.
10. Serve as the subject matter expert during audits related to risk management and traceability.
11. Provide mentorship and guidance to junior engineers in risk management principles and best practices.
12. Stay current with industry trends, emerging technologies, and best practices in systems and risk engineering and neuromodulation & propose/implement improvements to existing systems and processes.

Skills & Experience

1. Bachelor’s degree in Engineering, Biomedical or Systems Engineering, or related field.
2. Proven experience in medical device risk management, with a focus on active implantable medical devices preferred.
3. Deep understanding of ISO 14971 and its application to medical device development is essential.
4. Experience with developing and maintaining requirements management systems and design traceability matrices.
5. Proven expertise in risk analysis tools and techniques such as FMEA and Hazard Analysis.
6. Strong knowledge of regulatory standards, including IEC 60601, IEC 62304, MDR, and FDA guidelines.
7. Excellent documentation skills with a high level of attention to detail.
8. Hands-on experience with active implantable medical devices or neuromodulation systems would be highly advantageous.
9. Proficiency in requirements management and risk management tools is beneficial.

This position offers an exceptional opportunity for a seasoned systems or risk engineer to elevate their career within the active implantable medical device industry. You’ll bring a strong technical foundation and outstanding problem-solving abilities, enabling you to excel in tackling complex, multi-disciplinary projects. Thriving in a fast-paced, collaborative setting, you will effectively balance independent initiative with teamwork, contributing to innovative solutions in a highly interdisciplinary environment. This role will leverage your expertise to mentor and guide team members, requiring exemplary communication skills—both written and verbal—to articulate technical concepts with clarity and precision.

About Us

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 PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information.

What We Offer

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.

Please note, due to the Christmas break, we will begin assessing applications in the first week of January. We look forward to hearing from you.