Post Market Surveillance Manager Jobs in Indiana

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.

• Stays current with and understands relevant 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 (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
• Authors, 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 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 new product development projects and/or market released product design changes
• Identifies anticipated project risks and determines appropriate contingency plan(s) with stakeholder and project team member input
• Stays current and understands product performance through review of registry data and journal articles
• Provides technical support for new product launches and market released product such as answering customer and sales force product questions

• Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency 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
• 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
• Understanding of finite element analysis modeling desired
• Working knowledge of ASME GD&T standards with application to product design required

• 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.
• 5 to 7 years of full-time (including relevant ZB Coop/Intern) engineering experience.

up to 10%

Salary Expectations

We are open to a wider range of experience for this role. Your experience will dictate the salary band we can target.

95k Min - 135k Max

Work Environment:

Hybrid, Typically 2 days remote and 3 days onsite each week. Located in Warsaw, Indiana