R&D Project Manager- 761

Medinol is hiring R&D Project Manager!

Job Description:

Manage Class III R&D projects focused on the creation of new products and improvements to existing products through an understanding of the underlying science and technology.

Lead the project through all phases of the project, from Concept Development to Product Launch- Develop project timelines, assemble required project teams, track the schedule and deliverables, and maintain effective communication throughout the project.

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
• Manage a project within standardized methods and project models
• Ensure the timely release of critical deliverables within the project
• 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
• Understanding of group dynamics to influence team members
• 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

Experience/skills required:

• BS in Engineering discipline or other relevant degree
• Skilled in product development processes and a general business understanding, preferably in the highly regulated medical device industry
• Industry experience of 5+ years including two years’ managing projects
• Ability to coordinate across disciplines and integrate all aspects of business as they impact development projects including negotiation of scope, roles and responsibilities, specifications, timelines, and resources - up, down and, across the organization
• Verification and Validation experience with FDA-cleared devices
• Experience with design of experiments, statistical analysis techniques, and data analysis tools
• Prior experience in interventional medical device is necessary.
• Prior history working in an FDA regulated development environment; specifically, ISO 13485
• Knowledge of FDA EFS/PMA requirements strongly preferred

About the company…

Medinol is dedicated to the science of cardiovascular intervention. For over 25 years, we have delivered over two million coronary stents to patients worldwide. Our products constantly stretch the limits of innovation and our cutting-edge technology continues to demonstrate extraordinary clinical results. We make our products in-house using proprietary manufacturing technologies that ensure consistently exceptional quality and safety. Medinol manufactures EluNIR™, the first elastomeric drug eluting stent. Now FDA approved and CE marked, EluNIR demonstrated excellent clinical outcomes and promising safety profile in two clinical studies and features the Flexx² catheter technology with a metallic spring-tip, resulting in unprecedented ease-of-delivery even in tough anatomies. A unique stent design provides low metal footprint and optimized vessel support, leveraged by an elastomeric coating that ensures excellent surface quality. Founded in 1992 by Dr. Judith Richter and Dr. Kobi Richter and privately held to this day, Medinol continues to benefit from the leadership and insight of its founders. With more than 300 employees on board, we proudly maintain our family spirit and entrepreneurial culture.