Clinical R&D Advisor

JOB DESCRIPTION:

The Clinical R&D Advisor will provide clinical knowledge, expertise, and direction relevant to manufacturing, quality, performance, and patient safety during all phases of development of a product or concepts to assure informed decisions are made.  

RESPONSIBILITIES:

• Support product development by contributing clinical knowledge to bench testing, performing in-vitro and /or in-vivo device evaluations, and assisting in the development of new test methods to provide a better understanding of device performance.
• Create clinical performance evaluation plans to assess physician acceptance and the expected performance of new products by interacting with appropriate personnel, (e.g., physicians, engineers, other clinical coordinators, regulatory affairs).
• Write device Instructions For Use (IFU).
• Participate in the Risk Analysis process for new or improved devices to ensure that potential risks to patients associated with the use of the device are identified and appropriately analyzed.
• Participates in the Product Action process by performing and documenting a Health Hazard Assessment and communicating the assessment to Quality Assurance.
• Contribute clinical perspective to the decision-making process regarding product recall or field action by attending meetings with the Product Action committee, summarizing clinical feedback, performing product testing as needed, and providing general clinical knowledge and expertise.

• Establish and cultivate an extensive network of support to facilitate the completion of assignments.
• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
• Participate in determining goals and objectives for projects.
• Influence middle management on technical or business solutions.
• Exercise judgment in selecting innovative, practical methods to achieve problem resolution.

EDUCATION AND EXPERIENCE:

Required:

• Bachelor’s degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience preferred.
• Will consider certification in a related field or health industry with combined work experience.  
• RT, RN, or RCIS certification or degree
• 4–5-year recent catheter lab experience (coronary + endovascular ideal)
• Solid understanding and application of business concepts, procedures, and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Willingness to travel up to 30% (including international)

Preferred:

• Willingness to train to on-the-job skill sets:
• Simulated catheter lab product testing during product development
• Strong writing skills (protocols/reports)
• Strong verbal communication skills
• Interpersonal skillset interfacing with physicians
• Familiarity operating a fluoroscopy unit and operating in a fluoroscopy/sterile environment
• Experience as a scrub technician during procedures
• Experience working with medical device Quality systems and/or regulatory product approval processes
• Experience with Microsoft Office products, including PowerPoint for presentations and Excel for data analysis