Senior Catheter Development Engineer

1 month ago

Hayward, United States Pulse Biosciences, Inc. Full time

Pulse Biosciences

(Nasdaq: PLSE) 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 Nanosecond Pulsed Field Ablation (nsPFA) technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The Company is actively pursuing the development of its nsPFA technology for use in electrophysiology and the treatment of atrial fibrillation. Visit pulsebiosciences.com to learn more.

At Pulse, we: Exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. Take pride in hiring the best and brightest minds to our world-class company. Are individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude that will excel in our culture. About the Role

As the Sr. Catheter Development Engineer, you’ll be responsible for the technical development of catheters for the various applications that require the delivery of high-voltage nanosecond pulsed electric fields to achieve non-thermal tissue ablation. We are looking for a highly motivated, dedicated and enthusiastic medical device developer whose responsibilities will include taking concepts from early prototypes to volume production, developing comprehensive design documentation, working with physicians, medical facility personnel to obtain design feedback in a clinical environment, and developing close ties with new vendors. In this role, you will assume some project management responsibilities, including ensuring the objective and the scope of the project are well defined, and leading project or sub-project meetings.

You will make an impact by:

Designing and developing high-volume medical devices that can be manufactured via extruding, braiding, laminating, bonding, injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, etc. Prototyping and testing concepts for feasibility under tight deadlines. Analyzing data for efficacy. Contributing to the management of the catheter development with cross-functional teams following design control processes while generating medical product requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, in-vivo/in-vitro animal testing, DHFs, etc. Ensuring a smooth transition of new products into manufacturing. Assisting in training/overseeing technicians and assemblers. Contributing to the development of the company’s intellectual property portfolio. Contributing into the development of the medical devices safety and efficacy assessment via FEA, bench and animal testing. Understanding the company’s quality policy and quality system requirements applicable to tasks. To be successful, you will bring:

BS in mechanical, materials or equivalent engineering discipline is required. MS degree preferred. 5+ years of relevant medical product design and development experience in medical device industry required. 3+ years of experience designing and developing catheters required. Experience in developing catheters for energy delivery highly preferred. General knowledge of heart’s anatomy and functionality is highly preferred. Proven track record of generating innovative medical device concepts that can be turned into manufacturable products. Previous experience in ensuring a smooth transition to manufacturing. Demonstrated successful experience in managing internal and external development resources (e.g., consultants, consulting firms) to achieve product development goals. Startup experience a plus. Proficient knowledge and skill in Microsoft Office Suite applications. Comprehensive knowledge of SolidWorks CAD including drafting standards and GD&T. Ability to quickly learn and apply new software (e.g. COMSOL, PICO DAQ, etc.) and equipment (e.g. CellFX Console). Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques. Excellent oral written communication skills and critical thinking skills. Organized and proactive in following up on assigned tasks and setting expectations in timely manner. Exhibit a great attitude and flexibility as a team player who excels in a demanding start-up environment. Problem-solving ability, with an understanding of objectives and processes across multi-disciplinary functions involved in medical device development. Ability to present plans and results to multifunctional teams, accept constructive criticism, quickly learn from mistakes and move on. Ability to travel up to 15% of the time. Overnight and/or international travel may be required. Ability to lift 10-15 pounds. You’ll experience:

Purposeful and rewarding work collaborating with bright and curious minds

Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment A variety of health insurance plans and supplemental insurance options. 401k retirement savings plan. Stock options awards and ESPP program. Paid time off, paid holidays, and flexible work schedule. Wellness program with free onsite gym, mindfulness classes and activities. A commitment to providing a respectful work environment to our diverse workforce.

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: $125K - $160K

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.

Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.

LOCAL CANDIDATES ONLY

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals. #J-18808-Ljbffr

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