Development Sr Engineer II

About the role

We are seeking a Senior Development Engineer to join our team at Zimmer Biomet. Our surgeon-guided semi- and fully autonomous robotic technologies aim to enhance patient outcomes and relieve pain worldwide. This role involves leading product development efforts from ideation to commercialization, collaborating with cross-functional teams, and adhering to regulatory requirements.

Responsibilities

• 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 Monogram products and instrument development with a firm grasp on design for manufacturing
• Lead efforts of new product development in design control, including the management and implementation of Monogram 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
• Interface with 3rd party suppliers, contractors, testing houses, etc.
• Aide in publication efforts with Clinical Affairs team
• Lead surgical demonstrations (live, cadaver, or video) to help formulate physician comments/ideas into meaningful design solutions
• 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
• Aid in other development projects as additional resource when needed, while balancing own workload

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 3+ years of experience
• Prior experience in medical device development required
• Strong experience with verification and validation writing
• Proficient with CAD. SolidWorks Required
• Understanding of medical device industry regulatory requirements required

Qualifications

• 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

Skills

• Design control activities and verification and validation activities with respect to medical device development
• Exposure or past experience working with Surgical Robotics is a huge plus

Benefits

• Development opportunities
• Robust employee resource groups (ERGs)
• A flexible working environment
• Location-specific competitive total rewards
• Wellness incentives
• A culture of recognition and performance awards

Pay

TBD

Schedule

TBD