Development Sr Engineer I

About the role

You have a key support role with significantly 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.

Responsibilities

• 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
• 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
• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance (includes completing tolerance stack-ups, benchtop sing 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 s methods and/or predictive modeling as required to evaluate new products, and complete s method validation
• Authors, reviews, presents and obtains cross-functional team member approval of design control and risk management documentation
• Supports Regulatory Affairs team with the creation of new product regulatory submission documentation, preparation of materials for and conducting pre-submission question regulatory meetings
• 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

Requirements

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 required
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 sing preferred; Minitab experience desired
Ansys Software proficiency desired

Qualifications

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

Skills

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

Benefits

Travel Expectations: Up to 5%

Pay

N/A

Schedule

N/A