Sr. Manager, R&D

Position Summary

Senior Research & Development Manager for Teleflex Interventional Urology is located in Pleasanton, CA. In this position the individual will provide management support for the design and development and testing of innovative, new products within the Interventional Urology space. Applies advanced technical principles, theories, and concepts in working on complex technical problems. Provides engineering leadership and management of projects from concept generation through to regulatory approval and commercialization. Provides support and leadership for projects as they move through Product Development Process including supporting customer-facing events with product demos, concept & feedback sessions and physician interviews. Responsible for defining skills and coaching engineers in customer interactions, specifically focusing on voice of customer, need translation, and product requirement generation for the design and development of medical devices and medical device patents. 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.
Provides design inputs to generate Design, Process, and User FMEAs, risk analysis, Corrective and Preventive Actions (CAPA), design verification and validation, process development and validation, root cause analysis, tolerance analysis, test method validation. Provides support and leadership for team to complete these activities appropriately. Understands industry and government regulations. Uses this understanding to coach engineers on methodologies and support submissions within Interventional Urology. Provides oversight and technical rigor assessments of the design, development and testing of delivery systems and implants, polymers, metals including Nitinol, stamping, extrusion, molding, machined parts, bonding and their performance in the product life cycle. Understands the impact of sterilization, shelf life and other use conditions on the design and materials.

Principal Responsibilities

•    Oversee and manage Research and Development efforts toward efficient completion of the Company goals and objectives.
•    Manage and coordinate the planning, scheduling, and budgeting related to all R&D activities.
•    Compile and provide budget inputs to yearly AOP process. Support budget annually to meet business objectives.
•    Ensure R&D efforts related to development of new products and design modifications of existing products follow Design Control procedures.
•    Interface with subject matter experts from outside sources, companies, and forums to maintain an understanding of new developments in medicine and engineering.
•    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.
•    Build a robust R&D function through hiring and development of engineers
•    Supervise Engineers and projects. May supervise Managers.
•    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 allows 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 10 years of medical device engineering experience
•    Past people management experience is required

Specialized Skills / Other Requirements

•    Exceptional 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, MDR, and FDA QSR.
•    Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Interventional Urology complies.
•    Ability to travel approximately 10% of the time in the US and internationally as needed. (Ability to manage travel and expenses per approved budget.)

The pay range for this position at commencement of employment is expected to be between $175,000 - $210,000, 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.