Design Quality Engineer
Core
Ensure software design and development meet global medical device requirements and security standards within an agile environment.
Role type
Design Quality & Compliance Engineer (Medical Device)
Builds
Compliant Software as a Medical Device (SaMD) platforms
Domain
Healthcare / Medical Device Regulation / Information Security
Deliverable
production ML models | product features
Required skills
IEC 62304, ISO 14971, ISO 13485, ISO 27001, cloud security, access control, network security, secure software development lifecycles
Preferred skills
SaMD experience, start-up or scale-up environment experience
Technologies
IEC 62304, ISO 14971, ISO 13485, ISO 27001
Responsibilities
Lead implementation and continuous improvement of design control processes across the software lifecycle; Partner with engineers and product managers to define and document requirements, risk controls, verification, and validation activities; Support creation and maintenance of technical documentation including risk management files and verification reports; Support external ISO 13485 and Notified Body audits; Champion compliance by translating complex standards into actionable processes for engineering teams
Seniority
Individual Contributor, mid-level to senior