Principal Engineer

Teleflex; Pleasanton (CA); On-site; USD 175,000 - 263,000; Full time

Job summary

Teleflex Interventional Urology is seeking a senior mechanical design engineer to lead development of groundbreaking, minimally invasive devices. You will mentor a skilled R&D team in a fast-paced environment, drive design for manufacturability, and ensure compliance with medical device regulations.

With a strong background in complex mechanisms and materials, you will influence next-generation products and collaborate across functions to deliver high-impact solutions that improve patient

Qualifications

• 12+ years of related experience with a bachelor’s in mechanical engineering, or 10+ years with a master’s, or 7 years with a PhD.
• Exceptional verbal and written communication skills.
• Design experience with injection molding, stamping, metal injection molding, springs and related fabrication processes.
• Medical device experience is required.

Responsibilities

• Lead all design efforts for complex mechanisms and systems.
• Mentor and guide R&D engineers and technicians; plan and assign tasks.
• Ensure compliance with FDA QSR, ISO13485 and related standards.
• Translate user and business requirements into product design specifications.
• Manage projects, including scheduling, budgeting, and documentation.

Skills

Mechanical design

Six Sigma design

Project leadership

Team mentoring

Effective communication

Education

Bachelor's degree in Mechanical Engineering

Master's degree (optional)

PhD (preferred)

Tools

SolidWorks

Mini-Tab

Job description

A global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Interventional Urology – The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
1. Roehrborn, Can J Urol 2017

Position Summary

Join our dynamic Interventional Urology business unit, where your expertise will play a pivotal role in shaping the future of healthcare. As a key contributor, you will help develop groundbreaking technologies that enhance patients' lives and empower healthcare professionals.

At our innovative R&D lab, you will use resources to turn creative ideas into reality. You can influence the design of next-generation, minimally invasive devices and work on exciting single-use technologies that redefine standards in urology.

Develops innovative products that address critical unmet needs for urological conditions. As an integral member of the R&D team, this position is primarily responsible for developing and improving innovative products.

Individuals in this role must be highly skilled mechanical design engineers experienced with complex mechanism design, implants, polymers, metals, including Nitinol, stamping, extrusion, molding, machine 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, the ability to apply advanced technical principles, theories, and concepts to complex technical problems, and strong communication skills are also keys to success in this role. The individual will work with and mentor a motivated team of engineers and make a significant impact on the overall business by developing innovative new products and improving existing ones.

• You are a multifaceted technical leader and role model for the team.
• Mentor, guide, supervise, train, and assist R&D engineers and Laboratory personnel in their work.
• You create a positive environment and thrive in creating a high-performing team.
• You enjoy taking responsibility for technical and project work.
• Plan and assign tasks to engineers, technicians, and administrative staff.
• You are an innovator and find solutions for the most complex problems.
• Ideation, concept generation, and patent disclosure submissions.
• Develop new products and product concepts using existing and emerging technologies per Design Control requirements.
• Design prototypes and feasibility models for proof-of-concept testing.
• Lead the DOE and reliability effort for the project.
• Develop new test methods as needed.
• Analytically assess data and test methods to evaluate designs and down-select.
• Peer review drawings and documents and provide input to ensure engineering rigor.
• Collaborate closely with suppliers to ensure component delivery and with assembly operators to ensure manufacturability of the innovative design.
• Lead overall design efforts, including design/process characterization, verification, and validation of new product designs.
• Support process development, tool development, and tool validation.
• Serve as the technical specialist for the organization in the application of electromechanical systems, advanced concepts, principles, and methods in an assigned area.
• Prepare, participate in, and lead Design Control documentation activities, Design Reviews, Quality Audits, and CAPAs.
• System leadership for DHF and DMR.
• Lead test protocol development, develop test methods with validation, and write test reports.
• Translate user and business requirements into product requirements and high-level product design.
• Experience with System architecture and concept design of complex mechanisms.
• Manage projects, including scheduling, budgeting, and documentation.
• Help align the team and business needs.
• Define customer requirements and engineering specifications.
• 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 with our shared values of Entrepreneurial Spirit, Building Trust, and Make It Fun enables us to deliver outstanding products and services that genuinely improve 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.
• Exceptional verbal and written communication skills.
• Design experience using injection molding, stamping, metal injection molding, springs, and related fabrication processes.
• Exceptional mechanical design skills on complicated mechanisms and systems.
• Experience in robotics, motor control systems, embedded systems, or hardware/software integration is a plus.
• Experience developing mechatronic products with IEC 60601 is a plus.
• Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR.
• Expertise in SolidWorks.
• Expertise in Mini-Tab.
• Medical device experience is required.

Specialized Skills / Other Requirements

• Mastery of all phases of product development, including design verification, validation, implementation, and manufacturing.
• Demonstrated history of products successfully reaching the marketplace.
• 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.

The pay range for this position at commencement of employment is expected to be between $175,400 - $263,100, 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.

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.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: Up to 10% (Domestic and internationally as needed)

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].