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

Elixir Medical does not discriminate on the basis of race, sex, color, religion, marital status, national origin, gender, sexual orientation, gender identity, age, military veteran status, disability or any other reason prohibited by law.