Sr. R&D 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 and machine shop, you will have the resources to turn creative ideas into reality. You can influence the design of next-generation, noninvasive devices and work on exciting single-use technologies that redefine standards in urology.

You may have the opportunity to gain a whole lifecycle experience, from concept to commercialization, while enjoying ample learning opportunities to grow your skills and career. If you are passionate about making a difference and ready to tackle meaningful challenges, we want you on our team!
 

Principal Responsibilities

We seek dynamic individuals with an entrepreneurial spirit to help us redefine product development. Here is what you can expect:
•    Creative Development: Bring your ideas to life by conceptualizing, prototyping, and testing innovative methods in rapid development cycles.
•    Collaborative Design Leadership: Develop and manage complex mechanism design projects, collaborating with talented professionals to shape current and future products.
•    Problem-Solving Excellence: Lead a team in overcoming technical challenges, ensuring smooth project delivery and practical solutions.
•    Analytical Impact: Utilize innovative analytical tools to enhance design outputs and drive excellence in our products.
•    Strategic Planning: Prepare and manage technical plans and schedules for new product development, ensuring alignment across all stages.
•    Cross-functional collaboration: Work alongside R&D teams and subject matter experts to provide essential resources and support.
•    Intellectual Property Leadership: Guide patent applications and work closely with our IP team to protect our innovations.
•    Rigorous Testing Protocols: Develop and manage comprehensive test protocols and reports to validate our innovative designs.
•    Mentorship and Supervision: Guide engineering and laboratory teams in prototyping, manufacturing, and testing, fostering a culture of collaboration and growth.
•    Documentation Accountability: Ensure the creation and maintenance of thorough project documentation, including Design History Files and Design Master Records.
•    External R&D Engagement: Assist in managing and directing outside research and development projects for broader insights.
•    Design Review Facilitation: Lead and participate in design reviews, contributing to the continuous improvement of our processes.
•    Vendor Collaboration: Identify and support component and process vendors, enhancing our supply chain effectiveness.
•    Ongoing Education: Stay ahead by attending seminars, engaging with industry literature, and joining peer groups.
•    Quality Assurance: Participate in quality audits and implement corrective actions to ensure product excellence.
•    Training and Development: Contribute to the growth of our engineering and laboratory teams through training and mentorship.

We welcome diverse perspectives and experiences as they drive innovation. If you are passionate about pushing boundaries and shaping the future of product design, we want to hear from you!
 

Education / Experience Requirements

•    Bachelor’s degree in engineering, biomedical engineering, Mechanical or related discipline, or related practical experience
•    Master’s Degree preferred.
•    Typically requires a minimum of 8 years of related experience with a bachelor’s degree in engineering or a related major or 6 years and a master’s degree or a PhD with 3 year’s experience or equivalent experience. 
 

Specialized Skills / Other Requirements

•    Strong mechanical design and analysis skills.
•    Proficiency in SolidWorks.
•    Proficiency in all phases of product development, including design, implementation, verification, validation, and manufacturing. 
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, MDD, and FDA QSR.
•    Experience developing mechatronic products with IEC 60601.
•    Medical device experience required.
•    Experience in concept to commercialization of at least one project.
•    Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
•    Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding, and various other medical device fabrication and design methods, is preferred.
•    Self-motivated individual with proven ability to work independently from objectives.
•    Proven problem-solving and troubleshooting skills.
•    Experience with quality management systems and medical device regulations.
•    Proven communication skills with cross-functional interaction.
 

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