Sr. Clinical Specialist, Clinical Engineering

About the Role

The Clinical Specialist, Clinical Engineering plays an integral part in the company’s product clinical trials and commercial use, ensuring our physician partners are properly educated and trained in the use of our products and are supported during clinical use to achieve optimal outcomes for their patients.  This position will require extensive hands-on work in the pre-clinical setting, simulated-use setting as well as the actual clinical use setting.  This position will be part of a team of clinical engineers that will be responsible for the education and training of physicians and their staff on the proper use of the company’s products, as well as providing support during procedures to ensure effective use of the Company’s products, such as in the cardiac surgery, electrophysiology lab or any other clinical setting.

To Make an Impact, You Will:

• Provide clinical support of innovative, reliable, and safe products that meet clinical needs and regulatory standards.
• Ensure the Company’s products meet market functional requirements for ease-of-use and ease-of-learning and are competitive in their market.
• Ensure the Company’s products meet international standards and expectations for human factors such as IEC 62366 Application of usability engineering to medical devices.
• Involved in the deployment of company devices into clinical environments, including setting up new devices, device testing, analysis, and validation.
• Provide on-site and remote support during pre-clinical and clinical procedures involving our products.
• Collaborate closely with healthcare providers to address technical issues and optimize device performance.
• Use educational materials such as manuals, guides, and presentations to assist healthcare providers in understanding and effectively using our products.
• Conduct comprehensive training sessions for healthcare professionals, including physicians, nurses, and technicians, on the use, operation, and maintenance of our products.
• Support the integration of clinical insights, user needs, and market feedback into product development to ensure products meet the demands of healthcare professionals and patients.
• Be a part of root cause analysis teams for any issues related to clinical performance ensuring timely and effective resolutions.
• Drive innovation by identifying emerging trends, technologies, and best practices in clinical engineering and medical device development.
• Support regulatory affairs to support regulatory submissions ensuring all clinical and engineering documentation is complete and accurate.

To Excel, You Will Bring:

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field or similar experience.
• 3+ years of progressive experience in clinical engineering, medical device development, or related field.
• Experience with Cardiac Ablation Procedures.
• Experience with Class II or Class III devices is highly desirable.
• Strong understanding of global regulatory processes, clinical testing requirements, and post-market surveillance.
• Deep knowledge of medical device design, engineering principles, regulatory requirements (e.g., FDA, ISO 13485), and quality standards. Experience with Class II or Class III medical devices is preferred.
• Strong analytical and problem-solving skills with a proactive approach to addressing challenges in the development and validation of medical devices.
• Excellent verbal and written communication skills, with the ability to convey complex technical information to both technical and non-technical stakeholders.
• Ability to effectively manage time, manage resources and multi-task.
• Ability and willingness to both "roll up sleeves" and think strategically.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• High level computer skills required (e.g. MS Word, Excel, PowerPoint).
• Ability to travel up to 60% of the time. Overnight domestic and/or international travel may be required
• Ability to lift 10-15 pounds.