About this role
Lead the development of compliant, scalable medical device software solutions. Manage and mentor software engineers while guiding technical strategy, ensuring full life-cycle delivery, and collaborating with cross-functional stakeholders.
Key Responsibilities
- Lead software engineering team
- Ensure end-to-end software lifecycle delivery
- Adhere to ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304
- Own architectural and technology decisions
- Manage project priorities, resources, and risks
Technical Overview
Ownership of the full software development lifecycle for medical device software, with adherence to ISO 13485, FDA 21 CFR Part 820, ISO 14971, and IEC 62304. Drives agile delivery (Scrum/Kanban), architectural decisions, and software scalability, reliability, and security, including cybersecurity considerations.
Ideal Candidate
The ideal candidate is an experienced Software Engineering Manager with strong medical device software delivery leadership, including end-to-end ownership of the software development lifecycle. They have hands-on familiarity with medical device regulatory standards such as ISO 13485, FDA 21 CFR Part 820, ISO 14971, and IEC 62304, and they lead agile engineering teams using Scrum and Kanban.
Must-Have Skills
Manage and mentor a team of software engineersOversee the entire software development lifecycleAdhering to medical device regulatory standards (e.g.ISO 13485FDA 21 CFR Part 820ISO 14971IEC 62304)Champion agile development methodologies (ScrumKanban)
Nice-to-Have Skills
SaMDSiMDDigital HealthAICybersecurity
Tools & Platforms
ScrumKanban
Required Skills
Software engineeringManaging a team of software engineersTechnical strategySoftware development lifecycleRequirements gatheringSoftware designImplementationTestingDeploymentMaintenanceISO 13485FDA 21 CFR Part 820ISO 14971IEC 62304CybersecurityRetrospective remediation of existing software design documentationCross-functional collaborationAgile development methodologiesScrumKanbanArchitectural decisionsTechnology selectionScalabilityReliabilitySecurity of software productsProject risk managementResource managementSaMDSiMDDigital HealthAI
Hard Skills
Software engineeringManaging a team of software engineersTechnical strategySoftware development lifecycleRequirements gatheringSoftware designImplementationTestingDeploymentMaintenanceMedical device regulatory standardsISO 13485FDA 21 CFR Part 820ISO 14971IEC 62304CybersecurityRetrospective remediation of existing software design documentationCross-functional collaborationAgile development methodologiesScrumKanbanArchitectural decisionsTechnology selectionScalabilityReliabilitySecurity of software productsProject risk managementResource managementClient software deliverablesSaMDSiMDDigital HealthAIRecruitonboardand retain engineering talent
Soft Skills
LeadershipMentoringClient facing engagement managementCollaborationAccountabilityContinuous improvementTechnical excellence cultureProactive risk identificationStakeholder managementCommunication
Keywords for Your Resume
Software Engineering ManagerMedical deviceSoftware development lifecyclerequirements gatheringdesignimplementationtestingdeploymentmaintenanceISO 13485FDA 21 CFR Part 820ISO 14971IEC 62304Cybersecurityagile development methodologiesScrumKanbanarchitectural decisionsscalabilityreliabilitysecuritySaMDSiMDsoftware development lifecyclecybersecurity
Deal Breakers
Must demonstrate leadership experience managing a team of software engineers, Must have experience adhering to ISO 13485, FDA 21 CFR Part 820, ISO 14971, and IEC 62304
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