Principal Engineer, R&D

Position Summary

Principal Research & Development Engineer for Teleflex Interventional Urology is in Pleasanton, CA. Develops innovative products that address important unmet needs for urological conditions. As an integral member of the R&D team, this position is primarily responsible for developing innovative new products and making significant improvements to existing products. Primary responsibilities include user needs assessment, ideation, rapid prototyping, concept down selecting, design and process development, characterization, testing and statistical analysis are keys to this position. 

Individuals in this role must be skilled as mechanical design engineers experienced with implants, polymers, metals including Nitinol, stamping, extrusion, molding, machined parts, bonding and other commonly practiced manufacturing methods.  Critical thinking, advanced six sigma design capabilities, design for manufacturing/reliability, knowledge of high-volume production methods, the ability to work in a fast-paced environment, apply advanced technical principles, theories, and concepts in working on complex technical problems with strong communication skills are also keys to success in this role.  The individual will be working with and mentoring a motivated team of engineers as well as making a big impact on the overall business by developing innovative new products and making significant improvements in existing products.
 

Principal Responsibilities

•    Develop new products and product concepts using existing and emerging technologies per Design Control requirements.
•    Mentor, guide, supervise, train, and assist R&D engineers and Laboratory personnel in their work. Assigns tasks to and directs engineers, technicians, and administrative staff.
•    Manage projects, including scheduling, budgeting and documentation.
•    Serve as the technical specialist for the organization in the application of advanced concepts, principles, and methods in an assigned area.
•    Define customer requirements and engineering specifications.
•    Ideation, concept generation and patent disclosure submissions.
•    Design prototypes and feasibility models for proof of concept testing.
•    Develop new test methods as needed.
•    Analytically assess data and test methods to evaluate designs and down select.
•    Peer review drawings and provide input to ensure engineering rigor.
•    Work closely with suppliers to ensure component delivery and assembly operators to ensure manufacturability of new design.
•    Lead overall design efforts including design/process characterization, verification and validation of new product designs. 
•    Prepare, participate in and lead Design Control documentation activities, Design Reviews, Quality Audits and CAPAs.
•    Direct and monitor outside research and development projects. 
•    Through seminars, literature and peer groups, stay current with technology, practices and general engineering knowledge related to one’s field.
•    Keep informed of new developments and requirements affecting the organization for the purpose of recommending changes in programs or applications. 
•    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

•    Typically requires a minimum of 12 years of related experience with a Bachelor’s degree in Mechanical Engineering; or 10 years and a Master’s degree; or a PhD with 7 years of experience 
•    Design experience using injection molding, stamping, metal injection molding, springs, and related fabrication processes.

 

Specialized Skills / Other Requirements

•   Exceptional mechanical design skills on complicated mechanisms and systems.
•    Expertise in SolidWorks.
•    Mastery of all phases of product development including design verification, validation, implementation and manufacturing. 
•    Demonstrated history of products successfully reaching the marketplace.
•    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.  

The pay range for this position at commencement of employment is expected to be between $165,000 - $185,000, 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.