Principal Engineer

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.

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.

Principal Responsibilities

• 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.

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.