R&D Biomedical Engineer - Project Manager @ ProArc Medical - August 201918 August 2019
Manage subcontractors working on various phases of multiple projects (Optic, Mechanical, Electrical), domestic and abroad (especially Europe)
Oversees performance of all contractors and reviews engineering drawings to make sure that all specifications and regulations are being followed.
Tracks and controls subcontractors schedule and associated costs to achieve completion of projects within time and monies allocated.
Enforce discipline change management protocol for scope/cost/schedule adjustments to subcontracted work; ensure change requests are timely, accurate and complete.
Administer review process between Subcontractors/Suppliers and design team.
Manage the definition, integration, execution and report of validation activities against use needs.
Provide training to urologists and hospital clinical staff on the use of the product
B.Sc. in Biomedical / Mechanical Engineering
3-5 years’ experience in a medical device company
At least 3 years' managing a large quantity of remote subcontractors from different functional and technological areas (Optic, Mechanical, Electrical)
Experience with CE & FDA requirements or Design Control for Medical Devices.
Knowledge and experience with environment, safety, biocompatibility and essential performance tests
Ability to effectively prioritize and execute tasks in a high-pressure environment
Ability to work efficiently with minimal supervision