Tiffany Chiu
Senior Specialist, Device Developement & Technology
- Role
- Senior Specialist at Merck
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
Experience
Senior Specialist
Jul 2024 — Present
Device lead for pediatric co-packaged combination product kits• Lead pediatric update and device working group meetings• Created and progressed design control activities (i.e. documentation, impact assessments, risk analysis, verification and validation activities, design reviews, etc) to ensure critical project milestones have been met to support development and filing timelines for varying programs.• Authored device related dossier sections to support EU and US commercial filing.• Authored device related dossier sections to support IND/CTA filing. • Supported EU and US RTQ responses.• Collaborated with multiple teams on updates to the pediatric white papers and pediatric playbook.• Collaborated with CMOs and suppliers regularly to ensure program compliance with standards and regulations.• Performed impact assessments for commercial program changes.• Co-lead MDR UDI compliance solution discussions for impacted pediatric programs.• Supported ISO 13485 Quality Plan activities.
Education
Drexel University
Bachelor's degree, Major in Biomedical Engineering, Minor in Psychology
2012 — 2017
Skills
- Data Analysis
- Social Media
- Time Management
- Solidworks
- Powerpoint
- Microsoft Excel
- Research
- Microsoft Word
- Matlab
- Creole
- Microsoft Office
- Autocad
- Lego Nxt Program
- Labview
- Teamwork
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.