Principal Engineer

Teleflex•Pleasanton, CA

5d•$175,400 - $263,100•Onsite

About The Position

The Principal Engineer is a technical leader on Teleflex’s Interventional Urology R&D team, developing and improving medical products that address unmet needs in urological conditions. The role contributes to innovative, minimally invasive devices and single-use technologies, from concept generation through design, verification, validation, and manufacturing implementation. The engineer applies advanced mechanical design expertise to complex mechanisms, implants, polymers, metals including Nitinol, and manufacturing processes such as stamping, extrusion, molding, machining, and bonding. The position also provides technical leadership, mentors engineers and laboratory personnel, and helps deliver products that improve patient care. The role leads project and system-level engineering work, including requirements definition, product architecture, design controls, design and process characterization, testing, reliability, and manufacturing support. It works with suppliers, assembly operators, internal teams, and outside R&D partners, and manages project schedules, budgets, and documentation. Work is performed in an office/professional environment, with domestic and international travel of up to 10% as needed.

Requirements

Typically, 12 years of related experience with a bachelor’s degree in mechanical engineering, 10 years with a master’s degree, or 7 years with a PhD.
Medical device experience is required.
Exceptional verbal and written communication skills.
Experience designing products using injection molding, stamping, metal injection molding, springs, and related fabrication processes.
Exceptional mechanical design skills involving complicated mechanisms and systems.
Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR.
Expertise in SolidWorks.
Expertise in Mini-Tab.
Mastery of all phases of product development, including design verification, validation, implementation, and manufacturing.
Demonstrated history of products successfully reaching the marketplace.
Perform duties in compliance with FDA Quality System Regulation (QSR), ISO 13485, Canadian Medical Device Regulations, and other international regulatory requirements applicable to Interventional Urology.

Nice To Haves

Experience in robotics, motor control systems, embedded systems, or hardware/software integration.
Experience developing mechatronic products with IEC 60601.

Responsibilities

Serve as a multifaceted technical leader and role model for the team.
Mentor, guide, supervise, train, and assist R&D engineers and laboratory personnel; plan and assign tasks to engineers, technicians, and administrative staff.
Promote a positive environment and help create a high-performing team aligned with business needs.
Lead technical and project work, find solutions to complex problems, and manage projects, including scheduling, budgeting, and documentation.
Generate ideas and concepts and submit patent disclosures.
Develop new products and product concepts using existing and emerging technologies in accordance with Design Control requirements.
Design prototypes and feasibility models for proof-of-concept testing.
Lead design of experiments (DOE) and reliability efforts; develop test methods as needed and analytically assess data and test methods to evaluate and down-select designs.
Peer-review drawings and documents to ensure engineering rigor.
Collaborate with suppliers to support component delivery and with assembly operators to ensure designs are manufacturable.
Lead design efforts, including design and process characterization, verification, and validation of new product designs.
Support process development, tool development, and tool validation.
Serve as the organization’s technical specialist in applying electromechanical systems, advanced concepts, principles, and methods in an assigned area.
Prepare, participate in, and lead Design Control documentation, Design Reviews, Quality Audits, and CAPAs; provide system leadership for DHF and DMR.
Lead test protocol development, develop and validate test methods, and write test reports.
Translate user and business needs into product requirements and high-level product design; define customer requirements and engineering specifications.
Direct and monitor external research and development projects.
Stay current with relevant technology, practices, engineering knowledge, and new developments or requirements affecting the organization; recommend changes to programs or applications.
Perform other duties assigned by the supervisor.
Contribute to the company’s shared-values culture and work collaboratively to deliver products and services that improve people’s lives.