Development Engineer I

Zimmer Surgical, Inc.•Broadview Heights, OH

1d•$64,000 - $80,000•Hybrid

About The Position

At Zimmer Biomet, the Development Engineer I supports new product design, development, and commercialization, and/or helps maintain innovative medical device products already on the market. The role contributes to Zimmer Biomet’s mission and market leadership in medical technology. With oversight from a supervisor and mentorship from senior peers, the engineer works on arthroplasty products throughout the development process. This includes understanding intended use, clinical procedures, and relevant regulations and standards; identifying and translating user needs into product requirements; designing products; supporting prototype development and evaluation; and creating production specifications. The role also contributes to design verification and validation, risk management, design control documentation, and the transfer of new designs to production. This is a hybrid position requiring four days on site per week in Broadview Heights, Ohio. Travel expectations are up to 5%. The expected compensation range is $64,000–$80,000 USD annually.

Requirements

Bachelor’s degree in Engineering.
Demonstrated written and verbal communication skills, including presentation skills.
Proficiency with Microsoft Office Suite software.

Nice To Haves

Experience with product design and development.
Knowledge of ASME GD&T standards and their application to product design.
Knowledge of manufacturing processes, including subtractive machining, anodization, additive manufacturing, forging, casting, and plastic molding, and of material science for new product development.
Knowledge of FDA QSR and EU MDR medical-device regulatory requirements and recognized technical product standards.
Statistics knowledge applied to sample-size determination and null-hypothesis testing.
Design for Six Sigma experience.
Parametric CAD modeling experience, preferably with CREO and SolidWorks.
Finite element analysis predictive-modeling experience.
Co-op experience.
Degree in Mechanical, Biomedical, or Aerospace Engineering.

Responsibilities

Stay current with relevant arthroplasty product intended use, clinical procedures, regulations, and standards.
Identify user needs through engagement with product users, often orthopedic surgeons, and observation of similar device usage.
Translate user needs into design requirements and inputs that address unmet market needs, business goals, global regulatory requirements, and recognized industry standards.
Create product designs that address targeted user needs and requirements, and document the rationale for design features.
Prepare and review information for invention disclosures and patents.
Initiate and coordinate prototype production and inspection, with instruction and support from cross-functional team members, for preliminary evaluation and design and process verification and validation.
Create product production specifications that account for manufacturability and inspection.
Identify and document critical-to-quality product features to support appropriate quality-control inspection plans.
Evaluate, verify, and validate designs against requirements and to reduce user risk, including tolerance stack-ups, benchtop testing, and simulated operating-room cadaveric product evaluations.
Author and present design-control and risk-management documentation, and obtain cross-functional team approval in accordance with company procedures and global regulatory requirements.
Support Quality, Sourcing, and Manufacturing teams with design-transfer tasks for production of market-release quantities.