Development Engineer I

Socket.dev; Warsaw (IN); On-site; USD 65,000 - 80,000; Full time

Job summary

Zimmer Biomet in Indiana seeks a Mechanical/Product Design Engineer to drive new medical device design, development, and commercialization, and to maintain market-ready products.

You will work under supervision with senior mentors, translating user needs into design inputs, ensuring compliance with FDA QSR and EU MDR, and collaborating on prototypes, verification, validation, and process validation for market release.

Qualifications

• Minimum B.S. degree from ABET-accredited school in Mechanical, Biomedical or related field.
• Knowledge of regulatory requirements (FDA QSR, EU MDR) and industry standards.
• Experience with product design and development desired.

Responsibilities

• Design, develop, and commercialize new medical device products.
• Identify user needs from surgeons and observe device usage.
• Translate needs into design inputs to satisfy market needs and comply with regulations.
• Create production specifications for manufacturability and inspection.
• Coordinate prototyping, verification, validation, and process validation with cross-functional teams.
• Prepare information for invention disclosures and patents.
• Support design transfer tasks to production and ensure market release readiness.

Skills

Written and verbal communication

Product design experience

ASME GD&T knowledge

Manufacturing processes knowledge

Regulatory knowledge (FDA QSR/EU MDR)

Statistics

Design for Six Sigma

Parametric CAD (NX)

Finite Element Analysis

MS Office

Education

ABET-accredited B.S. in Mechanical/ Biomedical Engineering or related field

Tools

NX Unigraphics

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 medica device products in order to further Zimmer Biomet's mission and grow Zimmer Biomet's market leadership position.

How You'll Create Impact

With oversight from supervisor and mentorship 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 an 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.
• 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 ADA.

What Makes You Stand Out

• 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 maufacturing 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; NX Unigraphics Software Proficiency desired
• Finite element analysis predictive modeling experience desired.
• Microsoft Office Suite software proficiency 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.

Travel Expectations

• Up to 5%

Expected Compensation Range

$65,000 - $80,000

EOE