Development Engineer II

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging.

As Development Engineer II, 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.

• Stay current with and understand relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• Identify user needs through engagement with product users (often orthopaedic surgeons) and observation of similar device usage.
• Translate 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.
• Create product designs which fully address targeted user needs/requirements, and author design rationale to document basis of all design features.
• Prepare and review information for invention disclosures and patents.
• Initiate, provide instruction for, and coordinate with support from Zimmer Biomet cross‑functional team members in the production and inspection of product prototypes for preliminary evaluation, final design verification, design validation and process validation.
• Create product production specifications which appropriately account for design for manufacturability (process capability) and inspection.
• Identify and document 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.
• Evaluate, verify and validate 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).
• Author, present and obtain 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.
• Support Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market‑release quantities.

• 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…