Sr. R&D Engineer

Teleflex - Pleasanton, CA

Full-time

Pleasanton, CA

Miscellaneous Manufacturing

About the position

The position is within the Interventional Urology business unit at Teleflex, focusing on developing innovative, minimally invasive medical devices that enhance patient care. The role involves contributing to the design and commercialization of next-generation urology products, particularly the UroLift® System, while working in a collaborative and dynamic environment that encourages creativity and professional growth.

Responsibilities

• Bring ideas to life by conceptualizing, prototyping, and testing innovative methods in rapid development cycles.
• Develop and manage complex mechanism design projects, collaborating with talented professionals to shape current and future products.
• Lead a team in overcoming technical challenges, ensuring smooth project delivery and practical solutions.
• Utilize innovative analytical tools to enhance design outputs and drive excellence in our products.
• Prepare and manage technical plans and schedules for new product development, ensuring alignment across all stages.
• Work alongside R&D teams and subject matter experts to provide essential resources and support.
• Guide patent applications and work closely with the IP team to protect innovations.
• Develop and manage comprehensive test protocols and reports to validate innovative designs.
• Guide engineering and laboratory teams in prototyping, manufacturing, and testing, fostering a culture of collaboration and growth.
• Ensure the creation and maintenance of thorough project documentation, including Design History Files and Design Master Records.
• Assist in managing and directing outside research and development projects for broader insights.
• Lead and participate in design reviews, contributing to the continuous improvement of processes.
• Identify and support component and process vendors, enhancing supply chain effectiveness.
• Stay ahead by attending seminars, engaging with industry literature, and joining peer groups.
• Participate in quality audits and implement corrective actions to ensure product excellence.
• Contribute to the growth of engineering and laboratory teams through training and mentorship.

Requirements

• Bachelor's degree in engineering, biomedical engineering, Mechanical or related discipline, or related practical experience.
• Typically requires a minimum of 8 years of related experience with a bachelor's degree in engineering or a related major, or 6 years with a master's degree, or a PhD with 3 years of experience or equivalent experience.
• Strong mechanical design and analysis skills.
• Proficiency in SolidWorks.
• Proficiency in all phases of product development, including design, implementation, verification, validation, and manufacturing.
• Exceptional verbal and written communication skills.
• Familiarity with ISO 13485, MDD, and FDA QSR.
• Experience developing mechatronic products with IEC 60601.
• Medical device experience required.
• Experience in concept to commercialization of at least one project.
• Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding, and various other medical device fabrication and design methods is preferred.
• Self-motivated individual with proven ability to work independently from objectives.
• Proven problem-solving and troubleshooting skills.
• Experience with quality management systems and medical device regulations.
• Proven communication skills with cross-functional interaction.

Nice-to-haves

• Master's Degree preferred.