R&D Project Manager - Medical device (Class III)

A leading Medical Device company is seeking a talented R&D Project Manager to manage Class III R&D projects focused on the creation of new products and improvements to existing products.

Job Details:

• Oversee and manage design-controlled product development efforts including definition of proper and testable product requirements, definition of product development milestones, conducting design reviews, and rigorous testing & analysis in support of verification and validation activities.

• Manage and lead teams of non-direct reports

• Create and manage project scope, schedule, and budget

• Monitor and maintain awareness of new and current product regulations and standards

• Schedule and lead meetings to coordinate inter-departmental project activities; including those necessary to resolve project issues.

• Ensure all aspects of the project are in compliance to internal procedures

• Effective communication with project stakeholders and management

• Communicate project status at defined intervals and meanings, and escalate any concerns to the Supervisor and associated Management representatives.

• Assure that all product and project deliverables (quality, performance, cost, schedule and revenue) are met.

Requirements:

• BS in Engineering or other relevant degree.

• Skilled in product development processes and a general business understanding in the highly regulated medical device industry.

• 5+ years of Industry experience.

• 2+ years of experience managing projects.

• Ability to coordinate across disciplines and integrate all aspects of business including negotiation of scope, roles and responsibilities, specifications, timelines, and resources.

• Verification and Validation experience with FDA-cleared devices

• Experience with design of experiments, statistical analysis techniques, and data analysis tools

• Prior history working in an FDA regulated development environment; specifically ISO 13485

• Knowledge of FDA EFS/PMA requirements - advantage