Zimmer Biomet
Overview
Join to apply for the
Development Principal Engineer I
role at
Zimmer Biomet This is a hybrid role, 3 days on-site per week in Warsaw, IN. 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. We are committed to providing mobility and renewed life to people around the world with a flexible working environment, location-specific total rewards, wellness incentives and a culture of recognition and performance awards. We are dedicated to creating an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging. 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 to support Zimmer Biomet’s mission and market leadership. You will identify and apply new technologies to serve these goals and mentor less senior Development staff within the department. What 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 to satisfy unmet market needs and achieve business goals while complying with global regulatory requirements and industry standards Creates product designs which address targeted user needs/requirements and authors design rationale Prepares and reviews information for invention disclosures and patents Initiates and coordinates with cross-functional teams in the production and inspection of prototypes for evaluation, final design verification, validation and process validation Creates production specifications accounting for design for manufacturability and inspection Documents critical to quality product features and ensures appropriate quality control inspection plans Evaluates and validates product designs relative to requirements and to reduce user risk in compliance with procedures and regulatory requirements (including tolerance stack-ups, benchtop testing and simulated operating room cadaveric evaluations) Supports product design transfer tasks with Manufacturing, Sourcing and Quality for market release Develops new test methods and predictive modeling as required and completes test method validation Authors and reviews design control and risk management documentation and obtains cross-functional approvals Supports Regulatory Affairs with regulatory submission documentation and pre-submission meetings
How You’ll Create Impact
Supports clinical affairs in creating clinical study plans and protocols for regulatory submissions and post-market surveillance Trains and supports Post Market Surveillance and Quality teams with product investigations May serve as a project manager for small-scale, lower-technical-complexity projects for new product development, market releases, transfers and/or design changes Creates, manages and communicates project timelines, budgets and resource plans to stakeholders Anticipates and seeks approval for incremental resources as needed Schedules and coordinates project team meetings; assigns and tracks tasks to timeline Communicates project status to leadership in recurring meetings Identifies risks and contingency plans with input from the project team Stays current on product performance through review of registry data and journal articles Trains and mentors less experienced Development Engineers and cross-functional peers Provides technical support for new product launches and market releases Identifies and develops new technologies and incorporates them into product designs to meet user needs and business goals
This 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 Out
Strong written and verbal communication skills; ability to deliver professional communications to a global audience Parametric CAD modeling experience preferred; NX Unigraphics proficiency desired Microsoft Office Suite proficiency required Experience with product design and development from user need identification to commercialization; medical device/orthopedic implant and instrument design desired Understanding of manufacturing processes and material science for new product development FDA QSR and EU MDR knowledge; global regulatory requirements knowledge preferred Statistics knowledge for sample size, DOE, and hypothesis testing preferred ANSYS proficiency desired Design for Six Sigma experience preferred ASME GD&T standards knowledge required Minitab experience preferred Finite element analysis predictive modeling experience preferred
Your Background
Minimum B.S. degree from an ABET-accredited school in Mechanical, Biomedical, Bioengineering or related disciplines Minimum 7 years of relevant engineering work experience (co-op/intern experience may be considered)
Travel Expectations: 10%
EOE
Seniority level: Mid-Senior level
Employment type: Internship
Job function: Engineering and Information Technology
Industries: Medical Equipment Manufacturing
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Join to apply for the
Development Principal Engineer I
role at
Zimmer Biomet This is a hybrid role, 3 days on-site per week in Warsaw, IN. 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. We are committed to providing mobility and renewed life to people around the world with a flexible working environment, location-specific total rewards, wellness incentives and a culture of recognition and performance awards. We are dedicated to creating an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging. 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 to support Zimmer Biomet’s mission and market leadership. You will identify and apply new technologies to serve these goals and mentor less senior Development staff within the department. What 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 to satisfy unmet market needs and achieve business goals while complying with global regulatory requirements and industry standards Creates product designs which address targeted user needs/requirements and authors design rationale Prepares and reviews information for invention disclosures and patents Initiates and coordinates with cross-functional teams in the production and inspection of prototypes for evaluation, final design verification, validation and process validation Creates production specifications accounting for design for manufacturability and inspection Documents critical to quality product features and ensures appropriate quality control inspection plans Evaluates and validates product designs relative to requirements and to reduce user risk in compliance with procedures and regulatory requirements (including tolerance stack-ups, benchtop testing and simulated operating room cadaveric evaluations) Supports product design transfer tasks with Manufacturing, Sourcing and Quality for market release Develops new test methods and predictive modeling as required and completes test method validation Authors and reviews design control and risk management documentation and obtains cross-functional approvals Supports Regulatory Affairs with regulatory submission documentation and pre-submission meetings
How You’ll Create Impact
Supports clinical affairs in creating clinical study plans and protocols for regulatory submissions and post-market surveillance Trains and supports Post Market Surveillance and Quality teams with product investigations May serve as a project manager for small-scale, lower-technical-complexity projects for new product development, market releases, transfers and/or design changes Creates, manages and communicates project timelines, budgets and resource plans to stakeholders Anticipates and seeks approval for incremental resources as needed Schedules and coordinates project team meetings; assigns and tracks tasks to timeline Communicates project status to leadership in recurring meetings Identifies risks and contingency plans with input from the project team Stays current on product performance through review of registry data and journal articles Trains and mentors less experienced Development Engineers and cross-functional peers Provides technical support for new product launches and market releases Identifies and develops new technologies and incorporates them into product designs to meet user needs and business goals
This 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 Out
Strong written and verbal communication skills; ability to deliver professional communications to a global audience Parametric CAD modeling experience preferred; NX Unigraphics proficiency desired Microsoft Office Suite proficiency required Experience with product design and development from user need identification to commercialization; medical device/orthopedic implant and instrument design desired Understanding of manufacturing processes and material science for new product development FDA QSR and EU MDR knowledge; global regulatory requirements knowledge preferred Statistics knowledge for sample size, DOE, and hypothesis testing preferred ANSYS proficiency desired Design for Six Sigma experience preferred ASME GD&T standards knowledge required Minitab experience preferred Finite element analysis predictive modeling experience preferred
Your Background
Minimum B.S. degree from an ABET-accredited school in Mechanical, Biomedical, Bioengineering or related disciplines Minimum 7 years of relevant engineering work experience (co-op/intern experience may be considered)
Travel Expectations: 10%
EOE
Seniority level: Mid-Senior level
Employment type: Internship
Job function: Engineering and Information Technology
Industries: Medical Equipment Manufacturing
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