Zimmer Biomet Warsaw , IN 46581
Posted 3 weeks ago
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 have a strong sense of belonging.
Duties
New product design, development, and commercialization of innovative medical device products.
Understand relevant arthroplasty product intended use, clinical procedures, and related regulations/ standards.
Identify user needs, translate targeted user needs into design requirements, and create product designs which address user needs, and
author's design.
Prepare and review information for invention disclosures and patents.
Initiate, provide instruction for, and coordinate with support from team members.
Create product production specifications, identify quality product features based on product intended use, design requirements, user
risks, and the design itself.
procedures and global regulatory requirements.
Support Quality, Sourcing and Manufacturing teams with new product design transfer tasks.
Develop new test methods and predictive modeling.
Duties Continued
Author, review, present, and obtain team member approval of design control and risk management documentation.
Support Regulatory Affairs team with the creation of new product regulatory submission documentation, preparation of materials for
and conducting pre-submission question regulatory meetings.
submission and post-market surveillance.
Train and support Post Market Surveillance and Quality team with product investigations.
Serve as a project manager for new product development, market released product manufacturing/sourcing transfers and/or market
released product design changes.
Create, manage, and communicate project timelines, budgets, and resource plans to stakeholders as directed by supervisor.
Anticipate and seek approval for incremental resources as needed.
Schedule and coordinate project team meetings.
Coordinate and assign to project team members and track project tasks to timeline.
Communicate project status to leadership.
Identify anticipated project risks, determine appropriate contingency plan(s) with project team member input, communicate risks, and
obtain supervisor approval to implement contingency plans.
Understand product performance through review of registry data and journal articles.
Provide technical support for new product launches and market released product.
Education Requirements
Requires a Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, Aeronautical Engineering or related field, or foreign equivalent. Requires 5 years of experience in in the job offered or related position.
Your Background Requirements
Requires experience with all of the following:
Parametric CAD modeling
NX Unigraphics Software
Finite element analysis predicative modeling
Microsoft Office Suite software
Product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through
commercialization
Medical devices, particularly orthopedic implant and instrument product design
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
Global medical device regulatory requirements
Statistics with application to sample size determination, design of experiments, and null hypothesis testing
Minitab
Ansys Software
ASME GD&T standards with application to product design; and
Design for Six Sigma
Alternatively, employer will accept Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, Aeronautical Engineering or related field, or foreign equivalent.
Requires 3 years of experience in the job offered or related position.
Travel Expectations
Up to 5% domestic travel required.
Role permits fully remote work throughout the US.
EOE/M/F/Vet/Disability
Zimmer Biomet