At a Glance
- Tasks: Ensure our software meets global medical device standards while collaborating with engineers and product managers.
- Company: Join Heidi, a pioneering healthcare tech company transforming clinician-patient connections.
- Benefits: Enjoy private medical cover, wellness stipends, learning budgets, and flexible working options.
- Other info: Fast-paced environment with opportunities for rapid career growth and meaningful work.
- Why this job: Make a real impact in healthcare by shaping compliant, innovative technology.
- Qualifications: Experience in Software as a Medical Device and knowledge of IEC/ISO standards.
The predicted salary is between 63000 - 77000 £ per year.
We’re Heidi. We're building the future of healthcare by giving every clinician the earth's finest AI Care Partner. In just 18 months, our clinical AI products have absorbed the administrative chaos of 73 million patient visits. Today, we support over 2.5 million patient sessions a week across 190+ countries. Healthcare systems are failing us; clinicians spend more time on documentation than on patients, and the human connection that makes medicine worth practicing is eroding. Our mission is simple: double the world’s healthcare capacity and strengthen the human connection at its heart.
The Role
As our Design Quality & Compliance Engineer, you’ll sit at the heart of Heidi’s mission to make world‑class care faster and safer through intelligent, compliant technology. Reporting into the Legal & Regulatory Affairs team, but working day‑to‑day within Engineering, you’ll be the key link ensuring our agile software development practices remain fully aligned with global medical device and information security standards.
Your core mission is to help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape how design inputs, verification, validation, and risk controls are captured, reviewed, and evidenced.
This is a hybrid role for someone who can masterfully implement compliance within a modern, agile software culture, enabling engineering teams to build quickly and safely, while ensuring every release stands up to regulatory scrutiny.
- 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.
What We Will Look For
- SaMD Experience: Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment.
- Standards: 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.
- Technical Skills: A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.
- Proactive & Detail-Oriented: A commitment to quality and the ability to drive tasks to completion in a fast-paced, high-growth environment.
- Collaboration & Communication: Excellent communication skills, enabling you to work effectively with internal teams (engineers, product) and manage external partners (auditors, customers).
- A Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.
How We Show Up
- Build for the next decade, not next quarter. Our targets are outrageous on purpose. The world's health doesn't have the luxury of incrementalism.
- Lead, don't wait. We treat tomorrow's problems today. Sometimes we build what's needed before it's wanted, and we're fine with that.
- Follow the evidence. Trust the patient. We pursue truth relentlessly. But when the subjective and objective disagree, we treat the patient, not the numbers. Ego is a comorbidity we can't afford.
- Own the outcome. Everyone here carries the company. Raise problems with solutions, solve them end-to-end, and never be a bystander.
- Ship, measure, go again. A button today, a workflow tomorrow. More iterations beat better planning. We're precise at pace, not reckless.
- Live in clinicians' reality. Not the ideal workflow, the twenty-patients-before-lunch actual one. We build for exhausted humans, and we'd better be decent ones while we do it.
Why Heidi?
You’ll join a team focused on real-world impact over imaginary valuations and glossy PR. We live and breathe the challenges of modern health systems, and are laser-focused on exacting the change we’d like to see. We’re medicos, engineers, builders, and designers who’ve felt the moral and practical toll of what non-care feels like. True A-players progress extremely fast here. The nature of the scale-up game is demanding, but we value sustainable performance and mental health. You're trusted to perform, and you set your schedule. We operate on outcomes > inputs, not process theatre. We all take the bins out, metaphorically and literally.
Building what we’re building isn’t always easy. But we didn’t choose easy, we chose to build something that actually matters. We hold ourselves to a higher standard because healthcare demands it. If you join Heidi, you recognise that the deeper question isn’t whether AI can solve the global healthcare crisis, but whose hands will shape it. The work is hard, but you will trust and admire the people you work beside, and rest easy knowing you’re doing the defining work of your career.
We take care of you.
- We offer comprehensive private medical and dental cover through Bupa
- 24/7 mental health, coaching and wellbeing support through Sonder
- a £100/month Healthy Heidi's wellness stipend
- a £500 home office budget
- a £700 annual learning and development budget
- 26 weeks paid primary parental leave and 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
- a hybrid working environment with 3 days in the office
Design Quality Engineer employer: Heidi
Heidi is an exceptional employer that prioritises diversity and inclusion, creating a vibrant work culture where every team member can thrive. With a strong focus on personal and professional growth, employees in the UK sales team benefit from ample opportunities to develop their skills while contributing to meaningful advancements in the healthcare sector. Joining Heidi means being part of a dynamic team that values connection, engagement, and innovation from day one.
StudySmarter Expert Advice🤫
We think this is how you could land Design Quality Engineer
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Heidi.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Heidi.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Heidi, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Design Quality Engineer
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Heidi.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Heidi.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Heidi. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Heidi. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Heidi
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Heidi’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
