
Phat Le Dong
R&D Engineer (Project Leader) @ USM Healthcare Medical Devices Factory JSC
About
Professional Summary- Dynamic R&D Engineer and Project Leader with over 5 years of hands-on experience in the full lifecycle of medical device development, from concept to commercialization. - Proven expertise in product innovation, clinical application, regulatory affairs (CE Marking and domestic registration), technical sales, and cross-functional collaboration with partners and surgeons.- Demonstrated strong capabilities in project management, market research, competitor analysis, and successful product penetration strategies.
Vietnam
Ho Chi Minh City
Medical Device
Commercialization, Product Innovation, Interpersonal Skills, Market Analysis, Microsoft PowerPoint, Creative Problem Solving, Product Quality, Timelines, Standard Operating Procedure (SOP), Interpersonal Communication, Document Management Systems (DMS), Cross-functional Team Leadership, Requirements Analysis, Problem Solving, Sales Presentations, Product Knowledge, Product Demonstration, Communication, Foundational Engineering, Pharmaceutical unit operations
Experience

R&D Engineer (Project Leader)
Ho Chi Minh City, Vietnam
Achievements: - Successfully developed and optimized a full range of trauma & orthopedic implants (bone plates, bone screws, interlocking nails, and surgical drapes), delivering enhanced functional quality and superior clinical outcomes for hospitals nationwide. - Led cross-functional teams across R&D, Regulatory Affairs, Product Management, Purchasing, and Manufacturing to accelerate product development timelines and ensure on-time commercialization. - Designed and implemented standardized operating procedures across all departments, creating a seamless end-to-end system from manufacturing to sales. - Spearheaded market launch strategies that enabled smooth clinical integration and rapid commercial adoption of new product lines. Responsibilities: - Led end-to-end product lifecycle for a wide range of medical devices, from initial concept and design through regulatory approval to full commercialization. - Directed cross-functional teams to drive key projects in the trauma & orthopedic portfolio, ensuring timely and high-quality delivery. - Supported regulatory submissions (Domestic registration and CE Marking), prepared mechanical & biological testing reports, and developed technical/marketing documentation. - Created comprehensive clinical application protocols and gathered surgeon feedback to optimize product performance and accelerate successful market launch. - Conducted in-depth market research, competitor analysis (features, specifications, and commercial strategies), and formulated targeted product penetration strategies. - Provided cross-organizational support in strategic market planning, complaint investigation, problem solving, and continuous technical improvement.

Surgical Technician/Technical Sales
TVT Medical Equipment CO.,LTD
Ho Chi Minh City, Vietnam
Achievements: - Mastered aseptic techniques and infection control protocols, ensuring a sterile surgical environment and optimal patient safety during trauma and orthopedic procedures. - Achieved outstanding sales results by promoting and successfully selling advanced cardiovascular products (peripheral stents and balloon catheters) to healthcare professionals. Responsibilities: - Presented and demonstrated medical devices to surgeons and healthcare professionals, clearly communicating product features, clinical benefits, and correct usage techniques. - Provided comprehensive intraoperative and postoperative clinical support during orthopedic surgeries, ensuring proper product application and high quality patient care. - Prepared documentation for product evaluations, tenders, and regulatory submissions to support successful procurement processes. - Represented the company at medical conferences, workshops, and exhibitions.

Biomedical Researcher
Ho Chi Minh City, Vietnam
Pharmaceutical Engineering Dynamic biomedical researcher in pharmaceutical engineering, equipping myself with the technical knowledge and skills necessary for a successful career in the pharmaceutical industry. My coursework has provided a strong foundation in the following areas: - Pharmaceutical Formula - Improvement for Therapeutic Agent - Drug delivery system - Pharmacokinetics
Phat Le Dong's Contact Information
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