Development Principal Engineer II

What You Can Expect

You have a design owner and/or project manager role with 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.

Additionally, you will identify and put into application new technologies to serve the above goals. You will mentor less senior Development staff within the department. You may be asked to direct the workload of less senior development staff.

How You'll Create Impact

• 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 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 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, verifies and validates product designs relative to design requirements and to reduce user risk in compliance
• Supports Zimmer Biomet 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
• Reviews, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process
• 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 for regulatory submission
• Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations
• Identifies anticipated project risks, determines appropriate contingency plan(s) with stakeholder and project team member input
• Trains and mentors less experienced Development Engineers and cross-functional peers on product design and development
• Provides technical support for new product launches and market released product such as answering customer and sales force product questions
• Identifies and/or develops new technologies and appropriately incorporates these in product designs to address user needs while meeting business goals
• Recognized internal product design technical leader.

What Makes You Stand Out

• Demonstrated excellent written and verbal communication skills including presentation skills for professional communications to a global audience base
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency desired
• Microsoft Office Suite software proficiency required
• Advanced demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization preferred; medical device particularly orthopedic implant and instrument product design desired
• Advanced 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 required; Minitab experience required
• Ansys Software proficiency desired.
• Demonstrated design for Six Sigma experience required; black belt preferred
• Advanced working knowledge of ASME GD&T standards with application to product design required.
• Finite element analysis predictive modeling experience preferred.
• Proficient with Microsoft Project

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.
• 8+ years of full-time engineering experience.

Physical Requirements

Travel Expectations

Up to 10% 

Salary Expectations: 

$142,000-$175,000