Senior Clinical Specialist, Clinical Engineering (2 Positions Available)

Pulse Biosciences•Hayward, CA

About The Position

Pulse Biosciences is a bioelectric medicine company developing its proprietary CellFX nsPFA technology, which uses nanosecond electrical pulses to ablate cells without thermally damaging adjacent noncellular tissue. The company is pursuing applications in the surgical treatment of atrial fibrillation and other selected markets. The Senior Clinical Specialist, Clinical Engineering supports the company’s products in clinical trials and commercial use. The role helps ensure physician partners and their staff are educated and trained, and provides support during product use to help achieve optimal patient outcomes. Work includes hands-on activity in pre-clinical, simulated-use, and clinical settings, including cardiac surgery and electrophysiology labs. The specialist works with clinical engineering colleagues, healthcare providers, and internal teams to support product deployment and use, address technical issues, inform product development with clinical and market feedback, and contribute to root-cause analysis and regulatory submissions. The role may also mentor other Clinical Specialists. Travel of up to 60% is required, and overnight domestic or international travel may be necessary.

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 explain complex technical information to technical and non-technical stakeholders.
Ability to manage time and resources and handle multiple tasks.
Ability to combine hands-on work with strategic thinking.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities in a dynamic, fast-growing company.
High-level computer skills, including MS Word, Excel, and 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.

Nice To Haves

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

Responsibilities

Provide clinical support for innovative, reliable, and safe products that meet clinical needs and regulatory standards.
Ensure products meet market functional requirements for ease of use and ease of learning and remain competitive.
Ensure products meet international human-factors standards and expectations, including IEC 62366 usability engineering requirements.
Help deploy company devices in clinical environments, including device 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 educational materials such as manuals, guides, and presentations to help healthcare providers understand and use products effectively.
Train physicians, nurses, technicians, and other healthcare professionals in product use, operation, and maintenance.
Integrate clinical insights, user needs, and market feedback into product development.
Participate in root-cause analysis for issues related to clinical performance and help ensure timely 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 sustain relationships with physicians and supporting healthcare professionals.
May mentor other Clinical Specialists on the Clinical Engineering team.