Authors, reviews, presents and obtains cross-functional team member approval of design control and risk management documentation
Creates product specifications which appropriately account for design for manufacturability (process capability) and inspection
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
Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features
Initiates, provides instruction for and coordinates with support from Zimmer Biomet cross-functional team members in the production and inspection of product
Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself
Prepares and reviews information for invention disclosures and patents
Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
What Makes You Stand Out
Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base
Design for Six Sigma experience desired
Parametric CAD modeling experience preferred; SolidEdge 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
Working knowledge of ASME GD&T standards with application to 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
Ansys Software proficiency desired
Your Background
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
1 to 3 years of full-time (including relevant ZB Coop/Intern) engineering experience.
Must have experience within Medical Device
Travel Expectations
Up to 5%
Salary Expectations
$70,000 - $90,000 USD
EOE/M/F/Vet/Disability
