Senior Clinical Specialist, Clinical Engineering (2 Positions Available)

Pulse Biosciences•Hayward, CA

About The Position

The Senior Clinical Specialist, Clinical Engineering supports Pulse Biosciences’ products in clinical trials and commercial use. The role educates and trains physician partners and their staff and supports product use during procedures to help achieve optimal patient outcomes. It involves hands-on work in pre-clinical, simulated-use, and clinical settings, including cardiac surgery, electrophysiology labs, and other clinical environments. The position supports product deployment and testing, usability and human-factors requirements, clinical and regulatory documentation, troubleshooting, and the integration of clinical insights and user feedback into product development. It also develops relationships with physicians and healthcare professionals and may mentor other Clinical Specialists. Travel of up to 60% is required, including possible overnight domestic and international travel.

Requirements

Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field, or similar experience.
At least 6 years of progressive experience in clinical engineering, medical device development, or a related field.
Experience with cardiac ablation procedures.
Strong understanding of global regulatory processes, clinical testing requirements, and post-market surveillance.
Deep knowledge of medical device design and engineering principles, regulatory requirements such as FDA and ISO 13485, and quality standards.
Strong analytical and problem-solving skills, with a proactive approach to challenges in medical-device development and validation.
Excellent verbal and written communication skills, including the ability to communicate complex technical information to technical and non-technical stakeholders.
Ability to manage time and resources and multitask.
Willingness to take a hands-on approach while also thinking strategically.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities in a dynamic, fast-growing company.
High level of computer skills, including MS Word, Excel, and PowerPoint.
Ability to travel up to 60% of the time, including possible overnight domestic and international travel.
Ability to lift 10–15 pounds.

Nice To Haves

Experience with Class II or Class III medical devices is highly desirable.

Responsibilities

Provide clinical support for products that meet clinical needs and regulatory standards.
Help ensure products meet market requirements for functionality, ease of use, and ease of learning, and are competitive in their markets.
Help ensure products meet international human-factors standards and expectations, including IEC 62366.
Support deployment of company devices in clinical environments, including setup, testing, analysis, and validation.
Provide on-site and remote support during pre-clinical and clinical procedures involving company products.
Collaborate with healthcare providers to address technical issues and optimize device performance.
Use manuals, guides, presentations, and other educational materials to help healthcare providers understand and use products effectively.
Conduct training for physicians, nurses, technicians, and other healthcare professionals on product use, operation, and maintenance.
Support integration of clinical insights, user needs, and market feedback into product development.
Participate in root cause analysis for clinical-performance issues and help ensure timely, effective resolutions.
Identify emerging trends, technologies, and best practices in clinical engineering and medical device development.
Support regulatory affairs with submissions and ensure clinical and engineering documentation is complete and accurate.
Develop and maintain relationships with physicians and supporting healthcare professionals.
May mentor other Clinical Specialists on the Clinical Engineering team.