Senior Development Engineer II

About the role

Zimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility. This role involves designing and developing innovative medical devices to meet unmet market needs and drive Zimmer Biomet's market leadership.

Responsibilities

• Stay current with and understand relevant product intended use, clinical procedures, and related regulations and standards.
• Identify user needs through engagement with product users and observation of similar device usage.
• Translate identified user needs into design requirements/inputs that satisfy unmet market needs while complying with global regulatory requirements and recognized external industry standards.
• Create product designs that fully address targeted user needs/requirements and author design rationale to document the basis of all design features.
• Prepare and review information for invention disclosures and patents.
• Initiate, provide instruction for, and coordinate with support from Zimmer Biomet cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation, and process validation.
• Create product production specifications that appropriately account for design for manufacturability and inspection.
• Identify and document critical to quality product features based on product intended use, design requirements, associated user risks, and the design itself.
• Evaluate, verify, and validate product designs relative to design requirements to reduce user risk (includes completing tolerance stack-ups, benchtop testing, and executing simulated operating room cadaveric product evaluations).
• Support Zimmer Biomet Quality, Sourcing, and Manufacturing teams with new product design transfer tasks for production of market release quantities.
• Develop new test methods and/or predictive modeling as required to evaluate new products and complete test method validation.
• Author, review, present, and obtain cross-functional team member approval of design control and risk management documentation as part of the product development process.
• Support Regulatory Affairs team with the creation of new product regulatory submission documentation.
• Support clinical affairs in the creation of clinical study plans and protocols for both new and market released products for regulatory submission and post-market surveillance.
• Train and support Zimmer Biomet Post Market Surveillance and Quality team with product investigations.
• May serve as a project manager for new product development projects and/or market released product design changes.
• Identify anticipated project risks and determine appropriate contingency plans with stakeholder and project team member input.
• Stay current and understand product performance through review of registry data and journal articles.
• Provide technical support for new product launches and market released products, such as answering customer and sales force product questions.

Requirements

• Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base.
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency desired.
• Microsoft Office Suite software proficiency required.
• Demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization desired; medical device particularly orthopedic implant and instrument product design desired.
• Demonstrated understanding of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development.
• FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge required; global medical device regulatory requirements knowledge preferred.
• Demonstrated working knowledge of statistics with application to sample size determination, design of experiments, and null hypothesis testing preferred; Minitab experience desired.
• Understanding of finite element analysis modeling desired.
• Working knowledge of ASME GD&T standards with application to product design required.