Reda Fornera
CTO @ Skaaltec | Technology Leadership in MedTech | Vagus Nerve Stimulation (VNS)
10+ years leading Agile teams in software development with a focus on compliance and delivery.
About Me
SmartVNS is a wearable Vagus Nerve Stimulation (VNS) device that boosts brain recovery without surgery.
As CTO, the focus is on technology leadership and execution: architecture decisions, technology roadmap, and shipping reliable systems. Regulatory documentation (FDA submissions, cybersecurity compliance, IEC 62304, ISO 13485). Strategic partnerships with consultant companies and CROs to scale execution. Complex product delivery gets decomposed into clear work packages that align engineering, clinical, and regulatory teams.
Previously: 10+ years leading software development in regulated medical device environments, delivering Class III implantable systems and PMA-grade documentation.
Work History
Chief Technology Officer
Skaaltec (Zurich ZH)
Mar 2026 - Present
- Technology Leadership: Architecture decisions, technology roadmap, and shipping reliable systems for SmartVNS wearable VNS device.
- Regulatory & Documentation: FDA submissions, cybersecurity compliance, IEC 62304, ISO 13485.
- Strategic Partnerships: Consultant companies and CROs to scale execution capacity.
- Work Package Creation: Decompose complex product delivery into clear work packages aligning engineering, clinical, and regulatory teams.
Medical Device Engineer Software (Project Manager)
Sequana Medical NV (Zurich ZH)
2022 - 2024
- Spearheaded two C# .NET software projects, consistently delivering ahead of schedule andmeeting all key milestones.
- Implemented software strategy as sole SME, enabling cross-functional teams to address complex issues more effectively.
- Implemented Kanban, facilitated daily stand-ups, and prioritized backlog—significantly boosting team throughput.
- Planned projects using the V-Model; designed test plans and drove verification activities, minimizing post-release defects.
- Managed Change Requests for firmware/software, ensuring swift approvals and maintaining project scope.
- Authored PMA-grade software & cybersecurity documentation for a Class III implantable device (FDA), securing first-pass approval.
- Supported Quality & Regulatory audits, guaranteeing full compliance with industry standards and preventing non-conformances.
Embedded Software Engineer
Sequana Medical NV (Bachenbulach ZH)
2021 - 2022
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Led cross-functional teams, coordinating with external contractors for new feature development, ensuring alignment with project objectives and successful implementation.
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Facilitated Scrum ceremonies and planning sessions with external contractors, driving effective collaboration, clear communication, and timely delivery of deliverables.
Software Engineer / Drone Developer (Fixed-term employment)
Rheinmetall Air Defense (Zurich ZH)
2020 - 2021
Software Engineer
IniVation AG (Zurich ZH)
2019 - 2020
Component Engineer
Schindler Elettronica SA (Locarno TI)
2016 - 2019
Various Short Terms Jobs as Software Developer
(Ticino)
2015 - 2016
Education
Master of Science
Embedded System
HES-SO
2013 - 2015
Bachelor of Science
Electronic engineer
Ecole d’ingénieurs et d’architectures Fribourg
2010 - 2013