Design Quality Engineer

United States Digital Space LLC

United States

Hybrid

USD 120,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Medical & dental care

Mental health support

Wellbeing coaching

Wellness stipend

Home office budget

Learning & development budget

Hybrid work (3 days in office)

Parental leave

Job summary

United States Digital Space LLC is seeking a Design Quality & Compliance Engineer to ensure agile software development aligns with global medical device standards. You will drive design control and compliance within the engineering team, shaping how inputs, verification, validation, and risk controls are captured and evidenced.

You will partner with engineers, product managers, and regulatory staff to advance SaMD initiatives while maintaining rapid delivery and patient safety at the forefront.

Qualifications

Experience delivering SaMD in startup/scale‑up environments.
Strong working knowledge of IEC 62304, ISO 14971, ISO 27001 and applying them practically.

Responsibilities

Lead design control across the software lifecycle in alignment with standards.
Collaborate with engineers and product teams to ensure requirements, risk controls, verification, and validation are clearly defined and traceable.
Assist with technical documentation, risk management files, verification reports, and change records.
Support audits by Notified Bodies focused on Design and Development.

Skills

SaMD experience

Regulatory standards

Technical security

Proactive & detail‑oriented

Collaboration & communication

Education

Bachelor’s degree (scientific/engineering/regulatory)

Job description

We’re the company.

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 the company 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 the company.

The Role

What you’ll do

As our Design Quality & Compliance Engineer, you’ll sit at the heart of the company’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 the company?

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 the company, 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.