R&D Manager

Position Summary

This role for Teleflex Interventional Urology Unit is based in Pleasanton, CA. The R&D Manager provides management support for the design, development and testing of innovative products that address important urological, urogynecology & colorectal conditions. This role requires application of advanced technical principles, theories, and concepts while working on complex technical problems. The R&D Manager provides engineering leadership and management of projects from concept generation through to regulatory approval and commercialization. The R&D Manager is responsible for defining skills and coaching engineers in customer interactions and needs translation, and product requirement generation for the design and development of medical devices. The role requires strong leadership and project management skills, and experience in mechanical design and analysis, product reliability, statistical methods and design for manufacturability, including high volume production methods.

Principal Responsibilities

•    Oversee and manage R&D efforts toward efficient completion of the Company goals and objectives.
•    Manage and coordinate the planning, scheduling, and budgeting related to all R&D activities.
•    Ensures high-quality R&D functional deliverables, including detailed review of design, risk, and other relevant Design Phase deliverables to ensure accuracy of content and compliance with Design Control Procedures.
•    Interface with subject matter experts from outside sources, companies, and forums to maintain an understanding of new developments in Interventional Urology space.
•    Partner with cross-functional teams and directly with customers to ensure development and testing of prototypes meet market and customer requirements.
•    Provide guidance and ongoing review in the development of final reports for regulatory submissions.
•    Supervise Engineers and projects.
•    Participate in the development of the Company's R&D standards and procedures.
•    Oversee the review of document changes for research and development impact.
•    Ensure compliance of department staff regarding job descriptions and training requirements.
•    Perform other duties as assigned by supervisor.
•    Contribute to our culture that thrives on shared values, with people at the center of all we do. Working together, our shared values of Entrepreneurial Spirit, Building Trust, and Make It Fun allow us to produce outstanding products and services that genuinely make a difference to people's lives around the world.
 

Education / Experience Requirements

•    Bachelor's Degree in Mechanical or Biomedical Engineering or related engineering degree.
•    Master's Degree preferred.
•    At least 8 years of medical device engineering experience and 2+ years of managerial level experience.
•    Proven experience with people management and managing projects effectively.
•    Proficiency in all phases of product development including concept development, design inputs/outputs; design verification & validation and market release.
•    Exceptional mechanical design and analysis skills.
•    Familiarity with ISO 13485, MDR, and FDA QSR
 

Specialized Skills / Other Requirements

•    Hands-on with mechanical devices and components; roll-up-your-sleeves approach with a high sense of urgency and drive for results, balancing creativity with implementation.
•    Prior experience with hand-held disposable medical devices is preferred.
•    Solid verbal communication and written documentation skills including report writing.
•    Proficiency in SolidWorks.

The pay range for this position at commencement of employment is expected to be between ($160,000 - $170,000)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#LI-EB1