Development Sr Engineer II

Zimmer Biomet; Warsaw (IN); Hybrid; USD 95,000 - 135,000; Full time

Job summary

Zimmer Biomet in Warsaw, Indiana is seeking a Design Owner/Project Manager to drive new product design, development and commercialization of innovative medical devices. You will partner with cross‑functional teams to translate user needs into design inputs and ensure design verification and validation.

The role requires strong CAD proficiency, regulatory knowledge (FDA QSR and EU MDR), and experience guiding projects from concept through launch.

Qualifications

• Minimum B.S. in an ABET-accredited engineering program.
• 5–7 years engineering experience; biomedical/medical device background preferred.
• Experience with design control and product development lifecycle.
• Knowledge of regulatory requirements (FDA QSR, EU MDR).
• Ability to lead cross-functional teams through design to launch.

Responsibilities

• Lead design owner and project management for new product design and commercialization.
• Translate user needs into design inputs and verification plans.
• Coordinate prototype production, design verification and validation.
• Prepare design history files and risk management documents.
• Support regulatory submissions and post‑market surveillance.

Skills

Parametric CAD modeling

NX Unigraphics

Microsoft Office

Regulatory knowledge (FDA QSR/EU MDR)

Project management

Statistics (Minitab)

Finite element analysis

ASME GD&T

Education

Bachelor of Science in Mechanical Engineering

Tools

Minitab

Job description

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 recognised.

What You Can Expect

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.

How You'll Create Impact

• 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

What Makes You Stand Out

• 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

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

  Travel Expectations

  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

  EOE/M/F/Vet/Disability