Development Sr Engineer II

Zimmer, Inc.•San Diego, CA

1d•$119,000 - $149,000•Remote

About The Position

In this role you will act as a design owner and/or project manager with responsibility for new product design, development, and commercialization and to maintain in the market innovative medical device products. You will actively contribute to Zimmer Biomet’s mission and grow its market leadership position.

Requirements

Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience required.
You have 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.
You have strong understanding of FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge.
You have working knowledge of ASME GD&T standards with application to product design.

Nice To Haves

Parametric CAD modeling experience (NX Unigraphics Software is preferred).
Experience with finite element analysis predictive modeling.
Demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization.
Demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing (preferably Minitab experience).
Proficient with Ansys Software.
Six Sigma experience.
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 highly preferred.
5 to 7 years of engineering work experience highly preferred.

Responsibilities

Identify user needs through engagement with product users (often Orthopedic Surgeons).
Translate targeted user needs into design requirements/inputs which satisfy unmet market needs while also complying with global regulatory requirements and industry standards.
Create product designs and will author design rationale to document basis of all design features.
Prepare and review information for invention disclosures and patents.
Work with cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation.
Create product production specifications for manufacturability (process capability) and inspection.
Identify and document critical to quality product features, associated user risks and the design itself for quality control inspection plans.
Evaluate, verify and validate product designs relative to design requirements aligned to global regulatory requirements (e.g. completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations).
Support the Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities.
Develop new test methods and/or predictive modeling as required to evaluate new products, and complete test method validation.
Support the Regulatory Affairs team (e.g. creation of new product regulatory submission documentation, etc.) and the Clinical Affairs team (e.g. creation of clinical study plans and protocols).