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As Development Engineer II, you have a key support role with expanded responsibility for new product design, development, and commercialization; and/ or to maintain in the market innovative medical device products in order to further Zimmer Biomet's mission and grow Zimmer Biomet's market leadership position.

• Stay current with and understand relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage.
• Tranlsate 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.
• Create product designs which fully address targeted user needs/ requirements, and autor design rationale to document basis of all design features.
• Prepare and review information for invention disclosures and patents.
• Initiate, provide instruction for and coodinate 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 which appropriately account for design for manufacturability (process capability) and inspection.
• Identify and document critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated.
• Evaluate, verify and validate product designs relative to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
• Author, present and obtain cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Zimmer Biomet procedures and global regulatory requirements.
• Support Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

• Demonstrated good written and verbal communication skills including presentation skills required.
• Knowledge of ASME GD&T standards with application to product design desired.
• Knowledge of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired.
• FDA QSR and EU MDR medical device regulatory requirements, and industry/ regulatory body recognized technical product standards knowledge desired.
• Statistics knowledge with application to sample size determination and null hypothesis testing desired.
• Design for Six Sigma experience desired.
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency desired.
• Finite element analysis predicative modeling experience 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.

• Minimum B.S. degree from and 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.
• 1-3 years of full-time (including relevant ZB Coop/Intern) engineering experience.

• Up to 5%