Development Sr Engineer II

Zimmer Biomet; San Diego (CA); On-site; USD 100,000 - 124,000; Full time

Job summary

Zimmer Biomet is seeking a design owner/project manager for new medical device design, development, and commercialization. You will work with cross-functional teams to translate user needs into compliant design inputs, develop production specs, and support regulatory documentation.

You will lead design transfer tasks, verification/validation activities, and test method development, leveraging NX Unigraphics, ANSYS, and Minitab in a fast-paced environment.

Qualifications

• Bachelor's Degree in Engineering; 5 years of relevant experience required.
• ABET-accredited or global equivalent engineering degree preferred.

Responsibilities

• Lead design ownership for new medical devices from concept to commercialization.
• Coordinate cross-functional teams for design verification, validation and production readiness.
• Develop production specifications to ensure manufacturability and inspection.
• Support regulatory submissions and clinical study planning as needed.
• Document design rationale and facilitate invention disclosures and patents.

Skills

CAD modeling

Project management

Product design

Statistical methods

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

NX Unigraphics

ANSYS

Minitab

Excel

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

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.

How You'll Create Impact

• You will need to stay up to date with and understand relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• You will identify user needs through engagement with product users (often Orthopedic Surgeons).
• You will translate targeted user needs into design requirements/inputs which satisfy unmet market needs while also complying with global regulatory requirements and industry standards.
• You will create product designs and will author design rationale to document basis of all design features.
• You will prepare and review information for invention disclosures and patents.
• You will 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.
• You will create product production specifications for manufacturability (process capability) and inspection
• You will identify and document critical to quality product features, associated user risks and the design itself for quality control inspection plans
• You will 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).
• You will support the Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities.
• You will develop new test methods and/or predictive modeling as required to evaluate new products, and complete test method validation.
• You will 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).

What Makes You Stand Out

• Ideally you have parametric CAD modeling experience (NX Unigraphics Software is preferred).
• Ideally you have experience with finite element analysis predictive modeling.
• Ideally you have demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization.
• You have demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing (preferably Minitab experience).
• You are proficient with Ansys Software.
• Ideally you have Six Sigma experience.

Your Background

• Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience required.
• 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.
• 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.

Travel Expectations

• Up to 5% travel might be required.
• Expected compensation for the role is $100,000 - 124,000 base per year plus performance bonuses.

EOE