Sr Product Development Engineer

About the role

Paragon 28, a Zimmer Biomet company, is seeking a Senior Product Development Engineer (E4) to join their innovative team in Englewood, Colorado. This role focuses on shaping the future of extremity orthopedics.

Responsibilities

• Lead product development efforts from ideation to commercialization
• Research and evaluate products, parts, processes for efficiency and reliability
• Conceptualize new design ideas while understanding the inadequacy of existing designs
• Parametric modeling and detail design of P28 implant and instrument development with a firm grasp on design for manufacturing
• Assist junior Engineering staff with modeling and detailing methodology
• Lead efforts of new product development in design control, including the management and implementation of P28 design history files
• Lead design efforts to minimize patient risk and adhere to regulatory requirements
• Lead in development of testing protocols and assist in the testing process for new and existing products
• Analyze test results and recommend appropriate design changes
• Formulate complete test strategies and test reports with R&D and regulatory
• Work with Marketing to determine how data or analysis could be used for education or as selling tool in abstract/poster or white paper
• Interface with 3rd party suppliers, contractors, testing houses, etc.
• Aid in publication efforts with Clinical Affairs team
• Lead surgical demonstrations (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions
• Provide sales support via phone and live training as “expert” technical resource within specific product categories
• Compile invention disclosures for patent applications and infringement evaluations
• Participate in root cause analysis and corrective action development for design related issues in released product
• Lead other development projects as additional resource when needed, while balancing own workload

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline
• 6+ years of experience in medical device development
• Prior experience in medical device or similar product from ideation to commercialization
• Ability to read and interpret documents such as drawings, engineering specifications, testing standards, regulatory guidance documents, safety rules, company policy and procedure manuals
• Demonstrated ability to lead projects autonomously as part of a cross-functional team (Supply Chain, Marketing, Quality, Regulatory, etc.) and deliver updates to senior management
• Experience with designing for manufacturability, inspection and assembly
• Proficient with design control activities and verification and validation activities with respect to medical device development
• Understanding of medical device industry regulatory requirements
• Proficient with CAD
• SolidWorks preferred
• High proficiency in MS Office
• Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers
• Ability to work in a team environment

Benefits

This position offers a competitive total rewards package, including wellness incentives and a culture of recognition and performance awards. Zimmer Biomet is committed to creating an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging.