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The Opportunity

Atraverse Medical is an innovative, medical device start-up developing flexible left-heart access technologies to streamline procedures and improve patient outcomes. We are currently looking for a Principal R&D Engineer to join our team!

What you will do

The Principal R&D Engineer is responsible for designing and developing new products within a team environment and for providing sustaining engineering support for existing products in support of the company's innovative electrosurgical device program.

Responsibilites

• Translate customer and business needs into engineering specifications throughout the product design and development process.
• Develop detailed mechanical product designs and manufacturing fixtures through document control systems.
• Manage vendor supply chain sourcing including outsourcing of complex assemblies.
• Develop and execute test methods, protocols and reports to evaluate product acceptance criteria and document results.
• Participate in and/or lead design review meetings.
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Provide technical leadership to ensure project deliverables are met in a timely manner.
• Develop project timelines and schedules based on cross-functional team input.
• Manage project timelines and budgets. Experience with MS Project is preferred.
• Develop and execute process validation activities based on best practices
• Evaluate and implement design changes for existing products (sustaining engineering).
• Manage or mentor junior engineers.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.

Qualification and Core Competencies

• Bachelor's Degree in engineering related field or equivalent.
• Minimum of 10 years in design/engineering for medical device development and/or manufacturing.

Skills and Experience

• Experience with full life-cycle engineering, from concept (prototyping) to production transfer, for FDA-regulated Class II/III medical devices following design controls best practices.
• Expertise in component and assembly design using SOLIDWORKS.
• In-depth knowledge of commonly used manufacturing processes, construction, and assembly techniques, especially in the context of catheters and guidewires such as extrusion, molding, grinding, welding etc..
• Experience in material selection for medical devices especially for catheters and guidewires
• Experience in building and maintaining supplier relationships for sourcing key components and assemblies.
• Prior experience designing and developing catheters and/or guidewires in medium to high volumes
• Familiarity working in a dynamic office environment including laboratory, production areas, and controlled environment rooms.

Why should you join?

More than 1 million catheter-based procedures are performed worldwide in the left atrium of the heart each year. The ability to precisely locate the crossing site, safely traverse the septum, and deliver effective therapy is more important than ever. At Atraverse Medical, you will have the opportunity to observe this cutting-edge technology, while working as part of a highly diverse, motivated, and experienced team.

Additional Information

• ***Must live within commuting distance to Solana Beach, CA
• While performing the duties of this position, you will be required to stay in a stationary position and work on a computer for significant periods of time.
• Atraverse Medical offers Health, Dental, and Vision benefits to all full-time employees.
• Atraverse Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.