MDR - Prin R-D Engineer - Exempt

Join our team as a Principal R&D Development Engineer and play a pivotal role in designing and developing life-saving medical device products. Based in the vibrant city of Irvine, CA, you'll have the opportunity to work in a dynamic environment known for its innovation and proximity to leading medical technology companies.

Must Have:

• Catheter Design and Development
• Catheter Testing
• Failure Analysis and Root Cause Investigation
• Polymer Material Science

Key Responsibilities:

• Design and redesign medium to high complexity Neurovascular medical devices and subsystems.
• Support programs led by Sustaining and NPD functions.
• Test and optimize the design by designing and conducting relevant experiments and evaluations including numerical verification.
• Prepare full documentation in accordance with relevant internal SOPs and Design Control.
• Participate in pre-clinical in vivo labs, observing cases in hospitals and through planned and unplanned customer interactions.
• Create and evaluate prototypes to generate concept and model approvals.
• Write engineering reports and create presentations as required to document and communicate results.
• Prepare reports, presentations and spreadsheets of an analytical and interpretative nature.
• Institute design changes based on internal and external customer feedback.
• Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables.
• Contribute inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.
• Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity.
• Provide leadership, training and mentorship to less experienced team members.
• Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem-solving ability.
• Adhere to safety policy procedures.

Qualifications:

• Bachelor's degree in polymer science, Engineering, scientific, or technical discipline.
• 10 years of engineering experience.
• 6 years of medical device experience.
• Thorough understanding of Neurovascular medical device industry and competitor products. Working knowledge of other related disciplines.
• Thorough understanding of clinical and regulatory pathways, IP and internal processes.
• Experience with design remediation and CAPA management.
• Demonstrated ability to take initiative in keeping current with technology developments in specialized area.
• In-depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work.
• In-depth clinical knowledge for uses of product.
• In-depth knowledge of Neurovascular anatomy relative to surgical procedures for specific products.
• Ability to effectively communicate and work cooperatively with others as a lead member of a team.
• Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making.
• Expertise in catheter development and related processes.
• Equipment and tooling design.

Preferred Qualifications:

• Experience with Neurovascular products.
• Experience designing catheters and guidewire systems.
• Experience with metal process (braiding, coil, laser cutting, etc.) and polymer (extrusion, injection, blending, etc.) process, characterization and testing. Understanding on the process and property correlations.

Responsibilities may include designing, developing, analyzing, troubleshooting, and providing technical skills during research and/or product development. You'll design studies to investigate specific life science questions within your field of expertise and translate research discoveries into usable and marketable products.

As a recognized expert, you'll manage large projects or processes, exercising considerable latitude in determining deliverables of assignments with limited oversight from a manager. You'll contribute to defining the direction for new products, processes, standards, or operational plans based on business strategy, with a significant impact on work group results.

Join us in Irvine, CA, and be part of a team dedicated to making a difference in the medical device industry.