Ascend was a FDA Class 1 Medical Device Powered Knee Orthosis

Smart sensor technology provided support to users when performing common motions like walking, kneeling, standing, sitting, and going up or down steps. Ascend provides a safe, non-invasive and non-surgical option for pain relief and mobility constraints related to osteoarthritis, knee instability, and/or weak quadriceps.

My Role / Responsibilities: Technical Project Manager - Hardware

Project Management Methodologies: Waterfall (Hardware) and Agile (Software)

Cross-Functional Teams: Hardware, Software, Firmware, Controls, Compliance, QA, Manufacturing, Product, Sales, Marketing

Accomplishments:

• Coordinated efforts with Mechanical Engineers and contractors to reduce noise emissions by 7 dB to meet spec

• Created formalized Change Management Process, including documentation, impact analysis, approval, implementation, and verification

• Managed BOM for all hardware sub assemblies

Compliance and Certification:

• IEC 60601-1 (Medical Electrical equipment), UL, and Intertek, EMC Testing

Supply Chain:

• In House: Incoming inspections, quality control, and final device assembly

• Component Fabrication: Complex supply network, Contract Manufacturers mainly overseas in China and India

Project Management Software: ClickUp, Jira, Confluence, Arena, Smartsheet, Google Workspace