Development Sr Engineer I

Zimmer Biomet; Jacksonville (FL); On-site; USD 85,000 - 100,000; Full time

Job summary

Zimmer Biomet in Jacksonville, FL seeks an engineer to drive patient matched implant design and support manufacturing for innovative medical devices. You will work with surgeons and designers to translate user needs into feasible design inputs and robust product specs, ensuring manufacturability and regulatory readiness.

Ideal candidates have 3–5 years in medical device engineering, strong CAD/FEA skills, and experience with FDA QSR and EU MDR requirements.

Qualifications

• Minimum B.S. degree from an ABET accredited school in Mechanical/ Biomedical Engineering.
• 3–5 years of full-time engineering experience in Medical Device.
• Experience with design controls, risk management, and manufacturability.
• Familiarity with FDA QSR and EU MDR regulatory requirements.

Responsibilities

• Collaborates with surgeons and implant designers to develop patient matched implant designs.
• Investigates and dispositions non-conforming product with cross-functional support.
• Authors, reviews, and obtains cross-functional approval of design control and risk management documentation.
• Creates product specifications which account for design for manufacturability and inspection.
• Translates user needs into design inputs and requirements.
• Creates product designs addressing targeted user needs and documents design rationale.
• Prepares and coordinates with cross-functional teams in production and inspection.
• Evaluates, verifies and validates product designs to reduce user risk.

Skills

Communication skills

Design for Six Sigma

Parametric CAD modeling

Finite element analysis

MS Office

Regulatory knowledge

Ansys Software

Education

ABET-accredited BS in Mechanical Engineering (or related)

Tools

SolidEdge

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 key support role with Patient Matched Implants (PMI) and manufacturing support, with a potential for expanded 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

Collaborates with surgeons and implant designers to develop patient matched implant designs that suit the needs of the patient

Investigates and dispositions non-conforming product with support from Zimmer Biomet cross-functional team members

Authors, reviews, presents and obtains cross-functional team member approval of design control and risk management documentation

Creates product specifications which appropriately account for design for manufacturability (process capability) and inspection

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

Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features

Initiates, provides instruction for and coordinates with support from Zimmer Biomet cross-functional team members in the production and inspection of product

Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself

Prepares and reviews information for invention disclosures and patents

Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)

What Makes You Stand Out

• Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base
• Design for Six Sigma experience desired
• Parametric CAD modeling experience preferred; SolidEdge Software Proficiency desired
• Finite element analysis predicative modeling experience 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
• Working knowledge of ASME GD&T standards with application to 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
• Ansys Software proficiency desired

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
• 3 to 5 years of full-time (including relevant ZB Coop/Intern) engineering experience.
• Must have experience within Medical Device

Travel Expectations

5%

Salary Expecations

$85,000 - $100,000 USD

EOE/M/F/Vet/Disability