Pulsebiosciences
Senior Clinical Specialist, Clinical Engineering (2 Positions Available)
Hayward, CA - US Remote. Posted 18 days ago
The role
The Senior Clinical Specialist, Clinical Engineering provides clinical support, education, and training for products in pre-clinical, simulated-use, and actual clinical settings. This role involves supporting physician partners during procedures and collaborating with healthcare providers to optimize device performance.
What you will do
- Provide clinical support of products to meet clinical needs and regulatory standards
- Ensure products meet market functional requirements for ease-of-use and ease-of-learning
- Ensure products meet international standards for human factors
- Deploy company devices into clinical environments including setup, testing, analysis, and validation
- Provide on-site and remote support during pre-clinical and clinical procedures
- Collaborate with healthcare providers to address technical issues and optimize device performance
- Use educational materials to assist healthcare providers in using products
- Conduct training sessions for physicians, nurses, and technicians
- Support integration of clinical insights and user needs into product development
- Participate in root cause analysis teams for clinical performance issues
Required qualifications
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field or similar experience
- 6+ years of progressive experience in clinical engineering, medical device development, or 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, engineering principles, regulatory requirements (e.g., FDA, ISO 13485), and quality standards
- Strong analytical and problem-solving skills
- Excellent verbal and written communication skills
- 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
- High level computer skills (e.g., MS Word, Excel, PowerPoint)
- Ability to travel up to 60% of the time
Nice to have
- Experience with Class II or Class III devices
Benefits
- A variety of health insurance plans
- Supplemental insurance options
- 401k retirement savings plan
- Stock options awards
- Employee Stock Purchase Plan (ESPP)
- Paid time off
- Paid holidays
- Flexible work schedule
- Wellness program
- Onsite gym
- Mindfulness classes
About the company
Pulse Biosciences is a bioelectric medicine company that designs, produces, and commercializes nano-pulse technology. The company uses proprietary CellFX nsPFA technology to deliver nanosecond pulses of electrical energy.