Development Engineer II

Job Summary

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.

Principal Duties and Responsibilities:

With minimal oversight from supervisor and mentorship by senior peers:

Stays current with and understands 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

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

Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection

Identifies and documents 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

Evaluates, verifies and validates 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)

Authors, presents and obtains 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

Supports 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.

Expected Areas of Competence (i.e., knowledge, skills and abilities)

• 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

Education/Experience Requirements

• Minimum 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.
• 1 to 3 years of full-time (including relevant ZB Coop/Intern) engineering experience.

Travel Requirements

Up to 5%

What You Can Expect

How You'll Create Impact

What Makes You Stand Out

Your Background

Travel Expectations

EOE/M/F/Vet/Disability