Development Principal 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

• Stays current with relevant arthroplasty product intended use, clinical procedures, and related regulations and standards
• Identifies user needs through engagement with product users and observation of similar device usage
• Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards
• Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features
• Prepares and reviews information for invention disclosures and patents
• Initiates, provides instruction for and coordinates 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
• Develops new methods and/or predictive modeling as required to evaluate new products, and completes s method validation
• Supports Regulatory Affairs team with the creation of new product regulatory submission documentation
• Supports clinical affairs in the creation of clinical study plans and protocols for both new and market released products for regulatory submission
• Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations
• Identifies anticipated project risks, determines appropriate contingency plan(s) with stakeholder and project team member input
• Trains and mentors less experienced Development Engineers and cross-functional peers on product design and development
• Provides technical support for new product launches and market released product such as answering customer and sales force product questions
• Identifies and/or develops new technologies and appropriately incorporates these in product designs to address user needs while meeting business goals
• Recognized internal product design technical leader

Requirements

• Demonstrated excellent written and verbal communication skills including presentation skills for professional communications to a global audience base
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency desired
• Microsoft Office Suite software proficiency required
• Advanced demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization preferred; medical device particularly orthopedic implant and instrument product design desired
• Advanced 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 sing required; Minitab experience required
• Ansys Software proficiency desired
• Demonstrated design for Six Sigma experience required; black belt preferred
• Advanced working knowledge of ASME GD&T standards with application to product design required
• Finite element analysis predictive modeling experience preferred

Qualifications

• B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering
• 8+ years of full-time engineering experience