April Tsang Email & Phone Number

United States

Marlborough, Ma, Us

Supporting Endoscopy products by sustaining quality and compliance throughout the product lifecycle including implementing corrective actions, enhancing product reliability, complaint analysis and ensuring adherence to regulatory standards. Working closely with cross functional teams to drive continuous improvement initiatives to meet safety and performance standard to improve patient quality of life.

Marlborough, Ma, Us

Supporting Endoscopy Division EU MDR product submissions by updating DHF.Leading team of engineers for cross functional projects supporting EU MDR submissions, sustaining and new product development projects. Ensuring compliance with EU MDR regulations and standards by aligning documentation with MDR requirements.Supporting Internal Audits and External Audits.

Marlborough, Ma, Us

Supporting the Endoscopy division and products for EU MDR submissions including Class IIb, IIa and I products.Implementing design controls and risk management documentation updates to design history files (DHF) in compliance with EU MDR.

Bloomington, Indiana, Us

Led a team of engineers in executing risk analyses including Usability/Design FMEAs and Hazard Analyses (HA) for high priority product lines and regulatory submissions.Work specifically with Class III, IIb and IIa medical devices and meeting GSPR requirements within DHF files.

Bloomington, Indiana, Us

Human Factors/Usability Engineering SMEImplemented Human Factors principles and methodologies to the Quality Management System.Provided Usability Engineering Process training and daily consultation to Engineering teams.

Rochester, Ny, Us

Completed a presubmission to the FDA on the Dorsiflexion Assist Device. Teleconference with FDA in April 2019 to discuss regulatory pathway, product development feedback and proposed testing protocols.

Rochester, Ny, Us

Manage and advise two biomedical senior design Capstone projects. Guide students in design concept, design selection, prototyping, budgeting and project decisions through weekly meetings to discuss progress, challenges, future tasks and milestones.

Rochester, Ny, Us

8 week clinical immersion at the Strong Memorial Hospital. Over 125 hours of clinical observations for identifying unmet clinical needs in the operating room and acute rehabilitation unit. Orthopedic and Neurosurgical operating room observations include spinal fusion, laminectomy, craniotomy and Da Vinci Robotic surgeries. Acute rehabilitation observations include large range of therapeutic devices and SafeGait. Identified 120 unmet needs, assessed needs selection to one, transforming into Masters Capstone project. Worked with patients, physical and occupational therapists as key opinion leaders and voice of the customer feedback.

Binghamton, Ny, Us

Wearable Lactate Biosensors• Designed flexible and stretchable biosensor, in a team of three, to measure biomarker lactate levels in blood for wound care and clinical applications. Presented poster at Binghamton University’s Research Days 2018.• Fabricated a fractal pattern in AutoCad to mimic stretching of skin. Utilized a laser engraver to cut varying ratios of design on polyimide film. • Tested tensile stress and strain to validate biosensor mechanical properties using an Instron tensometer.Abstract:This study focuses on exploiting a flexible and stretchable biosensor design to measure levels of lactate in blood. Lactate is a biomarker for several biological reactions such as inflammation and wound healing. A fractal pattern was designed in AutoCad that mimics the stretching of skin. Laser engravers were used to cut varying ratios of the design as samples. Design analysis using a tensometer measured tensile stress and strain to validate the biosensors mechanical properties. Ultimately, the sensors would be used in point-of-care situations to have a better understanding of human physiology for clinical and diagnostic applications.

Binghamton, Ny, Us

Record lectures for distance learning students. Manage camera movement, soundboard and all technical requirements.

Master Of Science - Ms, Biomedical Engineering

Bachelor Of Applied Science (B.A.Sc.), Biomedical Engineering

Associate'S Degree, Liberal Arts And Sciences/Liberal Studies