Develop new processes for medical devices and components.
Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required.
Lead cross-functional team to plan and implement changes and improvements to operational systems and processes.
Manages complex cross-functional design and development projects on a first in class wearable device.
Works with cross-functional team to ensure timely and complete deliverable execution.
Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.
Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.
Serve as primary project coordinator for Quality Risk Management processes and strategic continuous improvement initiatives.
Collaborate with cross-functional teams to ensure compliant execution of quality risk activities and analyze QMS trends for improvement opportunities.
Provide administrative support, assist in authoring SOPs, and function as a Super User for QRM technology as needed.
Vertex Pharmaceuticals is a biotechnology company focused on discovering, developing, and commercializing innovative medicines for serious diseases. It has a global workforce and a culture centered on scientific research and improving patient lives through therapeutic breakthroughs.
Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development.
Lead human factor engineering activities as per the regulatory guidelines.
Manage project and program budgets and timelines effectively.
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind. They seem to have a collaborative culture.
Draft project charters, build and maintain detailed project plans, manage milestones and dependencies, and drive teams through to completion.
Analyze existing processes for bottlenecks and inefficiencies, then design and implement solutions that reduce cycle times and sharpen operational performance across the organization.
Develop and maintain SOPs, process flowcharts, and diagrams — partnering with functional SMEs to ensure documentation stays accurate, current, and usable in practice.
Personify Health created a personalized health platform—bringing health plan administration, holistic wellbeing solutions, and comprehensive care navigation together. Their team is on a mission to empower people to lead healthier lives with data-driven solutions that reduce costs while actually improving health outcomes.