Manager / Director, Research & Development
Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Identify market opportunities and propose/generate product projects to satisfy these opportunities in line with company goals
- Establish timing and performance goals for product projects
- Oversee and/or contribute to R&D project efforts
- Identify and research new technologies
- Initiate and develop relationships with key outside service and component vendors
- Generate systems and procedures to be used in product development
- Generate and review intellectual property applications
- Ensure company adherence to design control requirements
- Generate and maintain department budget
- Participate in review and maintenance of quality systems
- Adhere to the QSR systems, by following Good Manufacturing Practices (GMP) and FDA/MDD regulations by ensuring that you are current on all applicable training including SOP’s, manufacturing documents, and test methods
- Support company goals and objectives, policies and procedures, ISO/MDD requirements, the Quality System Regulation, and other regulatory requirements
- Identify, mentor and develop key talent
Qualifications
Experience
- Minimum twelve years of hands-on experience with Class III medical device product development with progressive management responsibilities
- Thorough understanding of medical device product development from concept initiation through product obsolescence
- R&D experience in neurovascular or structural heart including catheter design and stent design
- Previous experience as a medical device project leader
- Familiar with US and international medical device quality and regulatory standards
- Trained in medical device document control procedures
- Trained in medical device product verification and validation procedures
- Demonstrated track record of strong organizational and interpersonal skills
- Basic computer skills including Microsoft Word, Excel, PowerPoint and Project
Education Requirements
- Bachelor’s degree in science or engineering