Development Sr Engineer I

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 team member, you will share in our commitment to providing mobility and renewed life to people around the world. 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.

About the Role

You have a key support role with significantly expanded responsibility for new product design, development, and commercialization, and/or maintaining innovative medical device products in the market to further Zimmer Biomet’s mission and grow market leadership. This position is hybrid, requiring 4 days onsite per week.

Responsibilities

• Stay current with and understand relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• Identify user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage.
• Translate targeted user needs into design requirements/inputs that satisfy unmet market needs, achieve business goals, and comply with global regulatory requirements and industry standards.
• Create product designs that fully address targeted user needs/requirements and document the design rationale for all features.
• Prepare and review information for invention disclosures and patents.
• Initiate, provide instruction for, and coordinate cross-functional team support in producing and inspecting product prototypes for preliminary evaluation, final design verification, design validation, and process validation.
• Create product production specifications accounting for design for manufacturability (process capability) and inspection.
• Identify and document critical-to-quality product features based on intended use, design requirements, associated user risks, and the design itself to ensure appropriate quality control inspection plans.
• Evaluate, verify, and validate product designs relative to design requirements and reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements (includes tolerance stack-ups, benchtop testing, and simulated operating room cadaveric evaluations).
• Support 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 per Zimmer Biomet procedures and global regulatory requirements.
• Author, review, present, and obtain cross-functional team approval of design control and risk management documentation as part of the product development process.
• Support Regulatory Affairs with the creation of new product regulatory submission documentation, preparation for pre-submission meetings, and conducting those meetings.
• Support Clinical Affairs in creating clinical study plans and protocols for new and market-released products for regulatory submission and post-market surveillance.
• Train and support Post Market Surveillance and Quality teams with product investigations.
• Serve as a project manager for small-scale, lower technical complexity projects, including new product development, manufacturing/sourcing transfers, and market-released product design changes.
• Create, manage, and communicate project timelines, budgets, and resource plans to stakeholders.
• Anticipate and seek approval for incremental resources as needed.
• Schedule and coordinate project team meetings, assign tasks, and track progress to timeline.
• Communicate project status to leadership in designated recurring meetings.
• Identify anticipated project risks, determine contingency plans with stakeholder input, and obtain supervisor approval to implement them.

Requirements

• Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience.
• Understanding of various manufacturing processes (subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development.
• Knowledge of FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body-recognized technical product standards; global medical device regulatory knowledge preferred.
• Microsoft Office Suite proficiency.
• Working knowledge of ASME GD&T standards with application to product design.
• Design for Six Sigma experience desired.
• Parametric CAD modeling experience preferred; NX Unigraphics Software proficiency desired.
• Finite element analysis predictive modeling experience desired.
• Demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization; medical device, particularly orthopedic implant and instrument product design, desired.
• Ansys Software proficiency desired.

Qualifications

• Minimum: Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent.
• Degree from an ABET-accredited school (or equivalent) in Mechanical, Biomedical, or Industrial Engineering highly preferred.
• 3-5 years or more of full-time engineering experience highly preferred.

Schedule

Hybrid, 4 days onsite per week.

Travel Expectations

Up to 10%.

Pay

$80,000 - $100,000 USD / Annual.