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Development Sr Engineer I

1 month ago

Warsaw, United States Zimmer Biomet Full time

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 talent 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 included, respected, empowered, and recognized. 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 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 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 (process capability) and inspection Identifies 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 generated Evaluates, 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) 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 as required by Zimmer Biomet procedures and global regulatory requirements Authors, reviews, 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 requirements Supports Regulatory Affairs team with the creation of new product regulatory submission documentation, preparation of materials for and conducting pre-submission question regulatory meetings Supports clinical affairs in the creation of clinical study plans and protocols for both new and market released products for regulatory submission and post-market surveillance Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations May serve as a project manager for small scale, lower technical complexity projects for new product development, market released product manufacturing/sourcing transfers and/or market released product design changes Creates, manages and communicates project timelines, budgets and resource plans to stakeholders as directed by supervisor Anticipates and seeks approval for incremental resources as needed Schedules and coordinates project team meetings Coordinates, assigns to project team members and tracks project tasks to timeline 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 (including relevant ZB Coop/Intern) engineering experience. Travel Expectations Up to 5% EOE/M/F/Vet/Disability