What You Can Expect
You have a key support role with significantly 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.
How You'll Create Impact
- Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards
- Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals
- 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 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 and inspection
- Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself
- Evaluates and validates product designs relative to design requirements and to reduce user risk
- Supports Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities
- Develops new test methods and/or predictive modeling as required to evaluate new products, and complete test method validation as required
- Reviews, presents and obtains cross-functional team member approval of design control and risk management documentation
- 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
- Trains and supports Post Market Surveillance and Quality team with product investigations
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; 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
- Working knowledge of ASME GD&T standards with application to product design required
- 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, Aerospace Engineering or Aeronautical Engineering.
- 3 to 5 years of full-time engineering experience.
Physical Requirements
Travel Expectations
Up to 10% Travel
Salary Expectations:
$80,000-$100,000 USD
