Design Quality Engineer

Heidi; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Private medical and dental cover

Wellness and mental health support

Learning & development budget

Hybrid working environment

Parental leave

Zusammenfassung

Heidi is seeking a Design Quality & Compliance Engineer to join our Regulatory & Engineering efforts in Berlin. You’ll ensure software design and development meet global medical device requirements, implementing IEC 62304, ISO 14971 and ISO 13485 within an agile environment.

You’ll partner with engineers and product managers to define requirements, risk controls, verification and validation, while preparing documentation and supporting audits.

Qualifikationen

• Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.
• SaMD experience and regulatory background strongly preferred.
• Solid knowledge of IEC 62304, ISO 14971, and ISO 27001 and how to apply them practically.
• Experience with cloud security, access control, network security, and secure software development lifecycles.
• Ability to translate complex standards into clear, developer-friendly processes.
• Experience working in agile software environments with cross-functional teams.

Aufgaben

• Lead the implementation and continuous improvement of design control processes across the software lifecycle.
• Collaborate with engineers and product managers to define, document, and trace requirements, risk controls, verification, and validation activities.
• Maintain technical documentation, including requirements specifications, risk management files, verification reports and change records.
• Support external ISO 13485 and Notified Body audits, focusing on Design and Development aspects.
• Champion compliance by translating IEC/ISO standards into actionable, developer-friendly processes for the engineering teams.

Kenntnisse

SaMD experience

IEC 62304

ISO 14971

ISO 27001

Cloud security

Access control

Network security

Secure SDLC

Documentation & traceability

Collaboration & communication

Ausbildung

Bachelor’s degree or higher in a relevant scientific/engineering/regulatory discipline

Jobbeschreibung

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.

We found product-market fit with a freemium medical scribe that clinicians love. Now, we're expanding. Every task a clinician hands to Heidi is a patient who feels more attended to, a health system unclogged, and a clinician who gets to be a clinician again.

If you don’t choose easy and you want to build something way bigger than yourself then, choose the challenge, choose Heidi.

The Role

What You’ll Do

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.

What You'll Do

• 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, and a hybrid working environment with 3 days in the office.