Sr. Manager, Clinical Engineering

Pulse Biosciences • Hayward, CA

255d • $145,000 - $175,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Deep knowledge of medical device design, engineering principles, regulatory requirements (e.g., FDA, ISO 13485), and quality standards.
• 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.
• High level computer skills required (e.g. MS Word, Excel, PowerPoint).
• Ability to travel up to 30% of the time.

Nice To Haves

• Management experience building and leading a team is a plus.
• Ability and willingness to both 'roll up sleeves' and think strategically.
• Ability to lift 10-15 pounds.

Responsibilities

• Provide clinical leadership to ensure the development 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 FDA and international standards and expectations for human factors such as IEC 62366 Application of usability engineering to medical devices.
• Lead 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.
• Develop 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.
• Lead root cause analysis 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.
• Collaborate in development and management of budgets for all clinical engineering projects and adhere to company financial goals.
• Foster a culture of collaboration, innovation, and technical excellence across the clinical engineering team and with other departments.
• Build and mentor a high-performing clinical engineering team.

Benefits

• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP).
• Paid time off and paid holidays.
• Flexible work schedule.
• Wellness program, including onsite gym and mindfulness classes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree