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About the Role
As our Design Quality & Compliance Engineer, you will be instrumental in ensuring our software development practices align with global medical device and information security standards. You will focus on implementing IEC 62304, ISO 14971, and ISO 13485 within an agile environment, shaping how design inputs, verification, validation, and risk controls are managed.
Responsibilities
- Drive Medical Device Design Control Processes
- Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485.
- Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented, and traceable.
- Support the creation and maintenance of technical documentation, including requirements specifications, risk management files, verification reports, and change records.
- Support external ISO 13485 and Notified Body audits, with a focus on Design and Development aspects.
- Champion compliance in software development by translating complex and opaque IEC/ISO standards into clear, actionable processes that engineering teams can follow.
Requirements
- Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment.
- Strong working knowledge of standards such as IEC 62304, ISO 14971, and ISO 27001, and the ability to apply these in practical, developer-friendly ways.
- A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.
- A commitment to quality and the ability to drive tasks to completion in a fast-paced, high-growth environment.
- Excellent communication skills, enabling you to work effectively with internal teams (engineers, product) and manage external partners (auditors, customers).
Skills
- IEC 62304
- ISO 14971
- ISO 13485
- ISO 27001
- SaMD
- Healthtech
- Cloud Security
- Access Control
- Network Security
- Secure Software Development Lifecycles
Location
- Hybrid
Work Type
- Hybrid
Experience Level
- Start-up or scale-up environment experience
- Fast-paced, high-growth environment experience
Education Level
- Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.
Benefits
- Comprehensive private medical and dental cover through Bupa
- 24/7 mental health, coaching and wellbeing support through Sonder
- £100/month Healthy Heidi's wellness stipend
- £500 home office budget
- £700 annual learning and development budget
- 26 weeks paid primary parental leave
- 18 weeks paid secondary parental leave
- Fertility support up to £7,000
- Up to four weeks of work from anywhere per year
- Recharge Days after major milestones and busy periods
- 10 days per year of clinical leave for eligible clinical roles
About the Company
- We're building the future of healthcare by giving every clinician the earth's finest AI Care Partner.
- Our mission is to double the world’s healthcare capacity and strengthen the human connection at its heart.
- We found product-market fit with a freemium medical scribe that clinicians love.
- We build for the next decade, not next quarter.
- We lead, don't wait.
- We follow the evidence and trust the patient.
- We own the outcome.
- We ship, measure, go again.
- We live in clinicians' reality.
- We are focused on real-world impact over imaginary valuations and glossy PR.
- We are medicos, engineers, builders, and designers who’ve felt the moral and practical toll of what non-care feels like.
- We hold ourselves to a higher standard because healthcare demands it.