Hannah Chong

- Oversaw project management processes to support innovative technological advancements.

- Developed framework within National Healthcare Group to consolidate Intellectual Property and invest in new ventures.

- Assisted in submitting national grant proposals totaling over $10 million.

- Supported development initiatives for more than 200 start-ups and SMEs.

- Supported over 100 Clinician Innovators throughout their innovation journey.

- Enabled communication and collaboration among innovators, middle management, and senior leadership to foster an innovative environment in National Healthcare Group.

- Spearheaded the development of innovative manufacturing processes for Cardiovascular Catheters and Drug Delivery Stents, achieving key project milestones in biodegradable polymer development.

- Collaborated cross-functionally with teams in Quality Assurance, Logistics, Manufacturing, Regulatory, and Marketing to execute comprehensive product development initiatives.

- Led the development of product components with contract manufacturers, utilizing advanced injection molding techniques to enhance production efficiency.

- Engineered a cost-effective in-house blow molding process, resulting in $50K savings in development expenditures.

- Sourced and validated new raw materials and technologies for enhanced manufacturing capabilities in China and Singapore.

- Contributed to managing the Design History File (DHF) for ISO 13485 submissions, ensuring compliance and adherence to quality standards.

- Actively participated in product audits (CE, DEKRA), reinforcing regulatory adherence and product integrity.

- Engaged in quarterly Post Market Surveillance and Risk Assessment Reviews, maintaining rigorous oversight of product performance.

- Served as a key member of the product regulatory submission team, facilitating successful approvals.

- Developed sterilization methods for new products, optimizing safety and efficacy standards.

Managed Design Verification and Validation Testing (DVT) for an innovative drug-eluting stent delivery system, ensuring product reliability.

- Acted as an Independent Reviewer for project phase closures, providing critical assessments and insights.

- Obtained proficiency in ISO 25539 (Implants) and ISO 13485 (Medical Device Quality), enhancing regulatory knowledge.

- Executed technical transfers and new product integrations at manufacturing facilities in Singapore and China, ensuring seamless operations.

- Provided training to technicians and new engineers on advanced testing and processing methodologies, fostering skill development.

- Led and managed technicians' workflow and productivity.

- Offered technical expertise and support across various projects, driving innovation and quality within the organization.

- Delivered comprehensive engineering support to manufacturing operations, driving key business objectives.

- Developed and revised Standard Operating Procedures (SOPs) to ensure compliance with cGMP and Environmental Health & Safety regulations, enhancing Maintenance, Reliability, and Reproducibility.

- Managed and updated Bill of Materials (BOM), and Work Order Routings to streamline processes.

- Facilitated successful internal and external audits by regulatory bodies including DEKRA, FDA, and ANISA, ensuring operational compliance.

- Conducted root cause analysis on critical manufacturing issues, providing actionable recommendations and executing implementation plans.

- Collaborated with external vendors to design innovative manufacturing aids, improving production efficiency.

- Executed proof of concept experiments and evaluations to validate manufacturing processes.

- Supported New Product Transfer projects, including advancements in 2nd generation transcatheter heart valves.