Scientist

To implement, and support research investigations; to support professionalism and scientific expertise of department. Ensure the adequacy of pre-clinical testing protocols, both human and non-human in vivo studies. Assist Director or Project Leader and Project Manager with preparation of Scientific Development Plans. Assist academic and clinical researchers in the construction and conduct of study protocols. Develop and implement standardized processes for the timely construction of pre-clinical safety and performance studies as required by ongoing RAC, product development and regulatory projects. Assist in the guidance and direction of the development of internal biomechanical test methodologies. Identify, review and research emerging or innovative technologies, as needed. Initiate publication or presentation of data in professional journals or meetings. Ghost-write or co-author papers; assist surgeons on presentations. Initiate publications of own if corporate approved. Adhere to accuracy and timeliness of Development Plans and milestones. Assist in preparation of protocol, case report forms, informed consent and other specialized documents for clinical studies, as needed. Interview and recommend investigators for research studies, as needed. Support statistical department in statistical analysis of data. Assist regulatory affairs in preparation of safety, efficacy and performance summaries for regulatory submissions. Propose and initiate special projects that benefit the department. Serve as a consultant to management in areas of expertise. Maintain professional, product and market expertise via independent reading, training and networking. Follow department standard operating procedures. Minimum three years of prior experience in the research and development of orthopedic or osteo-biologic technologies or equivalent.

Bachelor’s degree in biomedical engineering, and/or biology/science is required. Demonstrated ability to build professional relationships within the academic and clinical research communities. Knowledge and experience with new product development and introduction processes are essential. Demonstrated understanding of the potential effects of alternative or innovative biomaterials, biologics and/or therapies. Experience reviewing and/or authoring scientific publications. Knowledge of FDA Medical Device Regulations and Guidelines. Must have ability to multi-task, be highly organized and detail oriented. Must have solid understanding of Microsoft Office. Excellent oral and written communication skills. Ability and desire to work effectively in collaborative, often multi-discipline team efforts. Self-starter who has the initiative, ability and interpersonal skills to interface with people inside and outside of the company exhibiting the highest level of professionalism. Approximately 60% travel

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=508650-3-143