Development Engineer I

Zimmer Biomet Team MemberAt 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, 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 have a strong sense of belonging.What You Can ExpectYou have a key support 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.This is a hybrid position, 4 days on site per week in Broadview Heights, Ohio.How You'll Create ImpactWith oversight from supervisor and mentorship by senior peers:Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standardsIdentifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usageTranslates 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 standardsCreates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design featuresPrepares and reviews information for invention disclosures and patentsInitiates, 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 validationCreates product production specifications which appropriately account for design for manufacturability (process capability) and inspectionIdentifies 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 generatedEvaluates, 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 requirementsSupports Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantitiesThis 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 OutAn entrepreneurial spirit characterized by intellectual curiosity, continuous learning, creative problem solving, and the willingness to step outside of their comfort zoneDemonstrated good written and verbal communication skills including presentation skills requiredExperience with product design and development desiredKnowledge of ASME GD&T standards with application to product design desiredKnowledge of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desiredFDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desiredStatistics knowledge with application to sample size determination and null hypothesis testing desiredDesign for Six Sigma experience desiredParametric CAD modeling experience preferred; CREO and SolidWorksFinite element analysis predicative modeling experience desiredMicrosoft Office Suite software proficiency requiredYour BackgroundRequired: Bachelor's Degree in EngineeringPreferred: Co-op experienceTravel ExpectationsUp to 5%Expected Compensation Range$64,000 - $80,000 USD / AnnualEOE