Principal Catheter R&D Engineer

We are expanding our innovative team with the addition of a Principal Catheter R&D Engineer. In this role, you will design and development of PFA catheters and accessories. This will include oversight of contract catheter development organizations.

Your Responsibilities

• Developing and evaluating new cardiac catheter technologies, materials and methods for PFA catheters.
• Coordinating verification and validation activities such as writing plans and reports, building prototypes, and supervising technicians.
• Transferring new designs from research and development into production. Oversee the writing of work instructions and training of operators. Assisting with development preventative maintenance schedules.
• Documenting components, designs, processes, and tools.
• Maintaining laboratory equipment, notebook and current training record.
• Providing technical leadership to engineers and/or engineering staff.
• Generate intellectual property.
• Translate Voice of Customer (VOC) input and translate that into product requirements and design specifications.
• Prepare reports and presentations to communicate technical assessments and analysis results.
• Work with external partners to move concepts into preclinical evaluation and clinical trials

Your Profile

Education / Experience Requirements

• Bachelor's degree in Mechanical Engineering, or equivalent.
• Minimum of 7 years of hands-on (not managerial) relevant cardiac catheter work experience.
• Experience with ablation technologies is highly desirable.
• Knowledge of CAD tools.
• Extensive practical experience designing cardiac ablation catheters.
• Demonstrated knowledge of cardiac catheter production techniques/processes.
• Practical experience with NiTi processes, catheter construction, electrode processing.
• Practical understanding of Design of Experiments (DOE), process validation and design control.
• Familiarity with cardiac catheterization procedures, tools, and terminology desired.
• Ability to work with external material and engineering vendors.
• Ability to communicate effectively, both oral and written, in order to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates
• Detail oriented with analytical mind-set, capable of root-cause analysis and problem-solving.
• Excellent written and verbal communication skills.

Physical and Travel Requirements

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week. Minimum to no work-from-home opportunity.
• Must be able to work onsite at our Tustin, CA facility. No relocation support will be provided.
• Must be able to travel up to 30% of the time.

Work Location

The location for this position is onsite, and will work out of our Tustin, CA office.

What We Offer

• Competitive base salary, with a negotiable performance bonus.
• Comprehensive benefits package.
• Opportunity to shape regulatory strategy for breakthrough cardiac technologies.
• A collaborative, mission‑driven environment where your expertise has immediate impact.

BIOTRONIK EP CRC is dedicated to fair and equitable compensation practices. The base salary range for this position is $130,000 – 150,000 per year, based on experience and qualifications. In addition to base salary, BIOTRONIK EP CRC offers a bonus program and comprehensive benefits package, which includes health insurance, retirement plans, paid time off, and other perks.

Compensation may vary depending on geographic location, skills, experience, and other factors.

About Us

BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

California Research Center Electrophysiology, Inc (CRC EP, Inc.), a BIOTRONIK business unit located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company’s PFA technology for treatment of atrial fibrillation. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.