Principal R&D Development Engineer

About the role

Primary Talent Partners has a new contract opening for a Principal R&D Development Engineer with our medical device client in Irvine, CA. This is a 6-month contract with a potential for extension. As a Principal R&D Development Engineer, you will design and develop life-saving medical device products.

Responsibilities

• Design and redesign medium to high complexity Neurovascular medical devices and subsystems.
• Supports 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
• 0+ 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.

Skills

• Catheter Design and Development
• Catheter testing
• Failure Analysis and Root Cause Investigation
• Polymer Material Science
• Preferred: Experience with Neurovascular products
• Preferred: Experience designing catheters and guidewire systems
• Preferred: Experience with metal process (braiding, coil, laser cutting, etc.) and polymer (extrusion, injection, blending, etc.) process, characterization and testing.
• Preferred: Understanding on the process and property correlations.

Pay