Development Engineer I

Zimmer Biomet; Broadview Heights (OH); Hybrid; USD 64,000 - 80,000; Full time

Job summary

Zimmer Biomet in Broadview Heights, OH is seeking an engineering professional to lead new product design, development, and commercialization of orthopedic devices in a hybrid work setting. The role requires a Bachelor's in Engineering, knowledge of ASME GD&T, CAD tools like CREO/SolidWorks, and familiarity with regulatory standards (FDA QSR, EU MDR); travel up to 5%.

You will collaborate with cross-functional teams to translate user needs into design inputs and support production transfer for

Qualifications

• Bachelor's Degree in Engineering is required.
• Experience with product design and development is required.
• Knowledge of ASME GD&T standards is preferred.
• Familiarity with FDA QSR and EU MDR medical device regulatory requirements is desired.
• CREO and SolidWorks proficiency is preferred.

Responsibilities

• Lead new product design, development, and commercialization.
• Maintain in-market innovative medical device products.
• Coordinate with cross-functional teams for prototype production and validation.
• Prepare design control and risk management documentation.
• Support design transfer tasks to production for market releases.

Skills

ASME GD&T

Product design

CAD modeling

CREO

SolidWorks

Finite element analysis

Regulatory knowledge

Microsoft Office

Education

Bachelor's Degree in Engineering

Degree in Mechanical, Biomedical, or Aerospace Engineering

Tools

CREO

SolidWorks

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 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.

What You Can Expect

You have a key support 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.

This is a hybrid position, 4 days on site per week in Broadview Heights, Ohio.

How You'll Create Impact

With Oversight From Supervisor And Mentoship By Senior Peers

• 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 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 (process capability) and inspection
• Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated
• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
• Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Zimmer Biomet procedures and global regulatory requirements
• Supports Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

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

• An entrepreneurial spirit characterized by intellectual curiosity, continuous learning, creative problem solving, and the willingness to step outside of their comfort zone
• Demonstrated good written and verbal communication skills including presentation skills required
• Experience with product design and development desired
• Knowledge of ASME GD&T standards with application to product design desired
• Knowledge of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired
• FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desired
• Statistics knowledge with application to sample size determination and null hypothesis testing desired
• Design for Six Sigma experience desired
• Parametric CAD modeling experience preferred; CREO and SolidWorks
• Finite element analysis predicative modeling experience desired
• Microsoft Office Suite software proficiency required

Your Background

Required: Bachelor's Degree in Engineering

Preferred

• Co-Op Experience
• Degree in Mechanical, Biomedical, or Aerospace Engineering

Travel Expectations

Up to 5%

Expected Compensation Range

$64,000 - $80,000 USD / Annual

EOE