Job Description |
Alteo is looking for a Product Owner for a permanent position. The company is located in the Greater Montreal area.
*** up to 100% Remote - Excellent working conditions ***
In this role you will collaborate with engineering, data science, QA/RA, clinical affairs, and external partners to deliver secure, scalable, and compliant solutions on time and within scope.
Responsibilities:
> Delivery Leadership
- Own end-to-end project planning, execution, and delivery for multiple concurrent software releases (Web, Mobile, SaaS, Data/ML).
- Maintain milestones, resource plans, and budgets; track KPIs (cycle time, velocity, quality, compliance).
> Technical Coordination
- Manage dependencies across teams (Dev, Data/ML, Security, DevOps, QA, Regulatory, Clinical) and third parties (EHR vendors, Consultants, CROs).
- Participate in customer meetings and act as a technical liaison.
> Quality, safety, and compliance
- Ensure deliverables align with QMS and regulatory frameworks (e.g., ISO 13485, 21 CFR Part 820/11, IEC 62304, ISO 14971, GDPR/HIPAA).
- Drive risk management activities (hazard analysis, FMEA), verification/validation planning (V&V), and design history documentation (DHFs).
- Assist with cybersecurity risk assessments (Threat Modeling, SBOM, vulnerability management), privacy-by-design (PbD), and secure-by-design (SbD) controls.
> Stakeholder and Customer Engagement
- Work with our Sales and Customer Success teams to interface with clinicians, researchers, and customers to capture requirements, clinical workflow nuances, and feedback.
- Prepare and deliver status reports, dashboards, and executive updates; proactively manage scope, risk, and change control.
Profile:
- DEC/BAC in IT, Software engineering or equivalent
- 5 years of experience in a similar role, including 2+ years in healthcare, life sciences, or medical devices.
- Proven delivery of cloud-based applications or clinical decision support, SaMD, or software components in regulated settings.
- Basic understanding of Microsoft Azure and Amazon AWS cloud platforms.
- Working knowledge of:
- SDLC and agile frameworks, backlog management, and release planning.
- Software fundamentals (APIs, microservices, data pipelines, cloud infrastructure).
- Data standards/interoperability (HL7, FHIR) and EHR integrations.
- Quality/regulatory concepts (IEC 62304 software classes, ISO 14971 risk management, 21 CFR Part 11 e-records/signatures, HIPAA/GDPR).
- Excellent communication skills with ability to translate between clinical/scientific, product, and engineering stakeholders.
- Strong analytical and problem-solving skills; experience with project management tools (Jira, Azure DevOps) and documentation systems.
- Experience in managing website development and integration projects (asset)
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