Sr. Biomedical Engineer, Research Scientist
The Sr. Biomedical Engineer/ Research Scientist will focus on identifying and investigating product concepts and technologies that will keep CSI in an arterial disease diagnosis and treatment leadership position long-term. This role will help to fill the new product pipeline by identifying novel investment opportunities that create a cadence of device improvements and innovations that support CSI’s future operating plan goals.
An ideal candidate would have education and experience that provides a depth of understanding in arterial anatomy and disease state as well as medical device design and development. This role will bridge between Clinical and R&D functions, so that clinical opportunities and unmet needs can be identified, understood and then translated into a timely medical device solution. The position requires a highly motivated, positive individual that can work both independently and in a team environment. This individual will need to interface and communicate effectively with physicians, hospital administration, external labs, academic researchers and scientists, CSI engineering, CSI sales & marketing and CSI clinical.
- Bachelor’s degree in Engineering, Technical, or Medical discipline
- Graduate degree(s) in a technical and/or biological discipline preferred
- 6+ years of experience at a medical device developer/manufacturer (Class II and Class III)
- Strong verbal and written communication skills with the ability to communicate ideas to all levels of the organization and external stakeholders
- Demonstrated capability to integrate complex clinical, technical and biomedical knowledge to formulate viable, cost effective medical device solutions
- Demonstrated competence and attention to detail when performing research, analytical testing, pre-clinical testing and medical device development
- Preclinical study activities with internal and external labs. Ability to consult and lead studies for multiple teams and technologies.
- Experience and history of animal study and cadaver design, strategy, regulatory justification, development, and study execution
- Experience in early stage designing, submitting and/or supporting stage clinical studies (FIH, EFS, IDE)
- Experience and history of submitting and review of preclinical materials to regulatory bodies (FDA, IACUC, EU, PMDA)
- Experience and history of corporate guidance, procedures, and templates.
- General working knowledge of intellectual property law and the generation of medical device IP and confidentiality rules.
- Able and willing to travel within and outside the US up to 20%, weekend and evening coverage (e.g. chronic studies) will also be required but minimal.
- Contributes to CSI’s body of scientific knowledge by authoring/coauthoring and/or presenting scientifically unique findings to either a CSI audience, regulatory bodies, or the medical and scientific community at large.
- Willingness to work in office, lab, and healthcare environments
Conduct research and development of new technologies, processes and systems that offer a significant growth and leadership opportunity for CSI.
- Interface with physician customers, hospital administration, academic researchers and industry leaders to identify unmet clinical needs.
- Perform research and testing (bench, animal, market) to better understand the unmet needs. Assist in the translation of unmet needs into thoughtful, comprehensive customer inputs.
- Collaborate cross-functionally to identify possible solutions to the unmet needs (customer inputs) based upon a thorough understanding of the problem. Present innovative approaches to complex problems.
- Assist in early-stage prototyping and development. Including methods for (e.g. prototype sterilization, study device requirements and methods)
- Responsible for the initiation, design, development, execution, and implementation of scientific research projects
- Investigates the feasibility of applying scientific principles and concepts to potential inventions and products.
- Maintains substantial knowledge of state-of-the art principles and theories and may contribute to scientific literature and conferences.
- May coordinate interdepartmental activities and research efforts.
- Proficient knowledge of medical terminology and scientific principles.
- Expertise with GLP and regulatory compliance guidelines.
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.