Zimmer Biomet

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.

• Evaluate, verify, and validate product designs relative to design requirements and to reduce user risk in compliance with company

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.

• Support 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.

• 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