Principal Engineer, Design Development, R&D

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.

Principal Responsibilities

•    You are the technical leader and role model for the team.
•    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.
•    You are an innovator and find solutions for the most complex problems.
•    Translate user and business requirements into product requirements and high-level product design.
•    Experience with System architecture and concept design of complex mechanisms.
•    Ideation, concept generation, and patent disclosure submissions.
•    Develop new products and product concepts using existing and emerging technologies per Design Control requirements.
•    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.
•    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, documents, and provide input to ensure engineering rigor.
•    Work closely with suppliers to ensure component delivery and assembly operators to ensure manufacturability of the 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 enable 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.
•    Design experience using injection molding, stamping, metal injection molding, springs, and related fabrication processes.
•    Exceptional mechanical design skills on complicated mechanisms and systems.
•    Expertise in SolidWorks.
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR.
•    Experience developing mechatronic products with IEC 60601 is a plus.
•    Medical device experience is required.
•    Experience in robotics, motor control systems, embedded systems, or hardware/software integration is a plus.

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.

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($170,000-185,000)  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.