Contact
Email: r2tjandr@uwaterloo.ca
LinkedIn: rickytjandra
Summary
Product and R&D leader with 6+ years of medical device industry experience, driving innovation from concept through FDA 510(k) clearance and commercialization. Skilled in product strategy, requirements gathering, roadmap development, and cross‑functional leadership. Proven record of aligning customer needs, clinical insights, and regulatory requirements to deliver impactful MedTech solutions.
Experience / Education
FluidAI Medical (formerly NERv Technology)
Director of Research | 2021–Present
- Lead our Regulated Medical Device (RMD) business unit.
- Defined and executed product strategy and roadmaps for biosensor‑based medical devices used in post‑operative complication detection.
- Led cross‑functional team to achieve first FDA 510(k) clearance, aligning product requirements with clinician feedback, regulatory expectations, and market needs.
- Partnered with surgeons, key opinion leaders, and hospitals to translate customer insights into product features, usability improvements, and evidence‑based validation.
- Expanded IP portfolio 6x over two years, securing over $200K in non‑dilutive funding.
- Built and managed a high‑performing R&D team; collaborated with engineering, manufacturing, and quality to ensure product scalability and compliance.
- Reported program and product health to C‑suite, clinical partners, and regulatory reviewers.
R&D Engineer | 2019–2020
- Prototyped and validated new sensor technologies for early device development and trials.
- Implemented ISO 13485 and FDA‑compliant design control processes for first device iterations.
- Supported preclinical and clinical studies, gathering data to demonstrate clinical and commercial value.
University of Waterloo
| PhD, Chemical Engineering (Nanotechnology) | 2015–2019 |
- Published 10+ peer‑reviewed articles with 300+ citations.
- Developed expertise in data analysis, experimental design, and technical communication.
Key Skills
- Product Management: Product strategy & vision, PRDs/SRSs, roadmaps, customer engagement, competitive analysis
- MedTech & Compliance: FDA 510(k), ISO 13485:2016, 21 CFR 11/820, HIPAA
- Leadership: Cross‑functional collaboration, KOL engagement, vendor partnerships, stakeholder alignment
- Technical: Medical devices, biosensors, data analysis (Python, Excel), Agile (Scrum), Jira, Confluence, Notion