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About the Role
As a Design Quality & Compliance Engineer, you will ensure our agile software development practices align with global medical device and information security standards. Your core mission is to help ensure our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304, ISO 14971, and ISO 13485 within an agile, iterative environment. You will 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.
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).
- A Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.
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
- Full-time
Experience Level
- Mid-level
Education Level
- Bachelor's degree or higher
Benefits
- $1,000 annual learning and development budget
- $150/month health and wellness allowance
- $500 home office budget
- 26 weeks paid primary parental leave
- 18 weeks paid secondary parental leave
- Fertility support up to $10,000
- Four weeks of work from anywhere per year
- Serious equity
About the Company
- We're building the future of healthcare by giving every clinician the earth's finest AI Care Partner.
- 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.
- Build for the next decade, not next quarter.
- Lead, don't wait.
- Follow the evidence. Trust the patient.
- Own the outcome.
- Ship, measure, go again.
- Live in clinicians' reality.
- 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.