Job Description
Job Description
Pulse Biosciences (Nasdaq : PLSE) : Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
- Our Mission : To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
- Our Culture : A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
- Our Commitment : Hiring the best and brightest minds to advance our world-class organization.
What You’ll Experience :
Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.About the Role
As the Senior Manager, Clinical Engineering you will play an integral part in the company’s product development from concept through 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. In collaboration with senior management, you will take a lead role while working cross-functionally to ensure the Company’s products are ergonomic, market competitive and highly functional in their unique clinical use setting(s). This will require extensive hands-on work in the pre-clinical setting, simulated-use setting as well as the actual clinical use setting. This may also require leading a small 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.
You’ll Make an Impact By :
Providing clinical leadership to ensure the development of innovative, reliable, and safe products that meet clinical needs and regulatory standards.Ensuring the Company’s products meet market functional requirements for ease-of-use and ease-of-learning, and are competitive in their market.Ensuring the Company’s products meet FDA and international standards and expectations for human factors such as IEC 62366 Application of usability engineering to medical devices.Leading the deployment of company devices into clinical environments, including setting up new devices, device testing, analysis, and validation.Providing on-site and remote support during pre-clinical and clinical procedures involving our products. Collaborating closely with healthcare providers to address technical issues and optimize device performance.Developing educational materials such as manuals, guides, and presentations to assist healthcare providers in understanding and effectively using our products.Conducting comprehensive training sessions for healthcare professionals, including physicians, nurses, and technicians, on the use, operation, and maintenance of our products.Supporting the integration of clinical insights, user needs, and market feedback into product development to ensure products meet the demands of healthcare professionals and patients.Leading root cause analysis for any issues related to clinical performance ensuring timely and effective resolutions.Driving innovation by identifying emerging trends, technologies, and best practices in clinical engineering and medical device development.Supporting regulatory affairs to support regulatory submissions ensuring all clinical and engineering documentation is complete and accurate.Collaborating in development and management of budgets for all clinical engineering projects and adhere to company financial goals.Fostering a culture of collaboration, innovation, and technical excellence across the clinical engineering team and with other departments.Building and mentoring a high-performing clinical engineering team. Setting objectives, performance goals and empowering them to deliver on the Company’s strategic priorities.To Excel, You’ll Bring :
Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field or similar experience.8 years of progressive experience in clinical engineering, medical device development, or related field, with at least 3 years in senior roles.Experience with Class II or Class III devices is highly desirable.Proven experience leading and managing cross-functional engineering and clinical teams with a track record of delivering successful products to market.Strong understanding of global regulatory processes, clinical testing requirements, and post-market surveillance.Management experience building and leading a team is a plus.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.Ability to drive innovation and provide direction in clinical engineering, with a focus on meeting both clinical needs and business objectives.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 30% of the time. Overnight domestic and / or international travel may be required.Ability to lift 10-15 pounds.Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.
Pay Range :
Compensation is determined based on a wide range of factors including job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range : $145K - $175K
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.
Salary : $145,000 - $175,000
