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.
What Makes You Stand Out
An entrepreneurial spirit characterized by intellectual curiosity, continuous learning, creative problem solving, and the willingness to step outside of their comfort zone
Demonstrated good written and verbal communication skills including presentation skills required
Experience with product design and development desired
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; CREO and SolidWorks
Finite element analysis predictive modeling experience desired
Microsoft Office Suite software proficiency required
Your Background
Required: Bachelor's Degree in Engineering
Preferred
Co-Op Experience
Degree in Mechanical, Biomedical, or Aerospace Engineering
Travel Expectations
Up to 5%
Expected Compensation Range
$64,000 - $80,000 USD Annually
EOE
