Linus Leung Email & Phone Number

Toronto, ON, CA

• Consulting for medical device companies on QMS requirements through application of ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR
• Implementing QMS for start-up companies
• Guiding Regulatory requirements on design controls, risk management, design/process V&V test planning

Marlborough, MA, US

• Continuously improving processes for team of Regulatory Affairs professionals to efficiently obtain approvals and launch new products in Canada, US, and EU.
• Created and maintaining high team engagement while leading team through significant organizational changes.
• Aligning department and organization with Regulatory projects and actions with dashboards.

Marlborough, MA, US

• Led team of Regulatory Affairs professionals to obtain 510k's, licences, and CE renewals/certifications to launch new products and product improvements in Canada, US, and EU.
• Established new process for team to create and gain stakeholder alignment on regulatory strategies for new products.
• Planned transfer of organization's product portfolio to EU MDR and drove the execution of DHF/DMR remediation and creation of technical documentation for submission.

Mississauga, ON, CA

• Leading team of Regulatory Affairs professionals to obtain approvals and launch new products in Canada, US, and EU.
• Developing Regulatory strategies for new product development and submissions.
• Improving product development process efficiency and consistency by introducing standardized work and outputs to Regulatory Team.
• Advising project teams on product development and DHF/DMR documentation strategies to ensure compliance to regulations.

Mississauga, ON, CA

• Led team of 13 on multiple device platforms to develop novel devices, complete design updates, new packaging design, and support quality system activities.
• Advanced company knowledge on clinical procedures and medical device packaging use workflow.
• Mentored and trained team to increase technical knowledge and to improve design and documentation strategies.
• Evaluate technical design and documentation.
• Developing new company procedures, strategies, and technical requirements through multidisciplinary teams to improve device designs and project efficiencies.

Mississauga, ON, CA

• Led 2 project teams to bring a new medical device to market from concept and to improve an existing device’s design.
• Effectively liaising with all stakeholders to ensure technical and project risks are mitigated and retired.
• Developing a high-performing team of 7 engineers on device design, testing, and risk management (NCR, CAPA, etc) activities.
• Motivated and directed my team to quickly adapt to changing priorities and unforeseen circumstances.

Mississauga, ON, CA

• Developed and implemented best practices for product development by devising new strategies and integrated document templates.
• As a part of the internal audit leadership, assisted in training of internal auditor members and team leaders.
• Consulted for other R&D teams on design, testing, and problem solving strategies.

Mississauga, ON, CA

• Designed prototypes of 3 novel cardiology medical devices, while testing them with physicians.
• Designed and implemented improvements to product features and manufacturing.
• Strategized and created design history files and completed verification/validation activities for regulatory submissions to Health Canada, FDA, Japan, EU.
• Improved infant patients’ care by bringing an existing device into a new jurisdiction, allowing a treatment that was not previously available.

Mississauga, ON, CA

• Completed verification and validation activities to support regulatory submissions and to extend product shelf life.
• Improved manufacturing processes through parametric studies and tooling modifications.
• Supported risk management activities such as complaints investigation, CAPA, and NCR.
• Advanced company procedures and processes by performing internal auditing and recommending changes.

Toronto, Ontario, CA

• Identified key parameters that controlled the material properties by conducting statistical parametric study on the manufacturing processes.
• Assessed essential polymer composite and biomaterial characteristics and structural relationships with physical, degradation, and mechanical properties under simulated working conditions.
• Exposed detrimental flaw in one of the most commonly used biomaterials by comprehensively studying a neglected property that is critical to material performance through a new testing technique.
• Innovated a novel fabrication method to infinitely increase the thickness of an electrospun film when the current gold standard has a limited thickness.

Toronto, Ontario, CA

• Established best practice protocol for corneal surgery suturing to improve surgery success rate.
• Applied expertise in standardized (ASTM) polymer testing procedures and equipment to the design of experiment, mechanical characterization, and data analysis.
• Utilized project management skills and team work through collaboration with two ophthalmologists.

Vancouver, British Columbia, CA

• Designed and built an advanced device for polymerization experiments under microgravity conditions.
• Successful implementation allowed for experiments to improve polymer property by 200%.
• Prepared comprehensive technical report on development and standard operating procedures of device.

• Assisted in the fabrication and characterization of semiconductor lasers.
• Designed and performed experiments to enhance device efficiency.
• Analyzed data and prepared a comprehensive technical report on the research.

• Designed a liferaft deployment system with new unique functions for ferries.
• Gained experience in producing technical manufacturing drawings of components and mechanical stress analysis on the structure.
• Assessed manufacturing costs and material sourcing for budget proposal.
• Performed AutoCAD drafting tasks for other product development engineers.

Ph.D., Mechanical Engineering

M.A.Sc., Mechanical Engineering

B.A.Sc., Engineering Physics - Electrical Engineering Specialization