Development Sr Engineer I

What You Can Expect

The Development Senior Engineer I will support the design, development, and commercialization of innovative medical device products within Infection Solutions, with an initial focus on technologies for infection prevention and treatment. Working with cross-functional teams and external partners, the role will help translate clinical needs and early-stage concepts into feasible, evidence-based product solutions that further Zimmer Biomet’s mission and market leadership position in musculoskeletal healthcare.

This is a hyrbid position, onsite 3 days per week in Warsaw Indiana. 

How You'll Create Impact

• Applies understanding of orthopedic infection prevention and treatment practices, clinical workflows, product intended use, and applicable regulations to identify user needs and translate them into clear design requirements and inputs with guidance from technical and cross-functional leaders.
• Develops and evaluates product concepts, documents design rationale and technology-selection decisions, and supports technical due diligence, intellectual property assessments, invention disclosures, and patent-related activities for defined workstreams.
• Plans and coordinates prototype development, inspection, and feasibility evaluations with cross-functional teams and external partners.
• Develops product and process specifications, identifies critical-to-quality attributes, and supports quality control strategies based on intended use, design requirements, material and biological performance, infection-relevant performance attributes, and user risks.
• Develops and executes fit-for-purpose test methods, models, verification, and validation activities to evaluate product performance including, where applicable, antimicrobial activity, biofilm-related performance, biocompatibility, elution or release kinetics, and relevant in vitro or preclinical model outputs and support design decisions in accordance with Zimmer Biomet procedures and global regulatory requirements.
• Supports design transfer, release, and post-market activities by partnering with Quality, Sourcing, Manufacturing, Sterilization, Packaging, Post Market Surveillance, and other functions on market-release readiness, investigations, and product support.
• Authors, reviews, and obtains cross-functional approval of design control, risk management, regulatory, and evidence-supporting documentation, including materials for regulatory submissions, regulatory interactions, and to support regulatory submissions and preclinical or clinical evidence plans.
• May serve as technical lead or project manager for feasibility workstreams and small-scale, lower-complexity projects involving new product development, technology integration, design changes, or manufacturing/sourcing transfers under appropriate supervision.
• Creates and communicates project plans, timelines, budgets, resource needs, technical deliverables, decision criteria, risks, contingency plans, and status updates to stakeholders and leadership.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Demonstrated strong written and verbal communication skills, with the ability to communicate technical information to cross-functional and global audiences.
• Design for Six Sigma, design of experiments, or structured product development experience desired.
• Hands-on prototyping and parametric CAD modeling experience preferred; NX software proficiency desired.
• Knowledge of biomaterials, surface modifications, coatings, polymers, hydrogels, antimicrobial technologies, biofilm prevention strategies, or controlled local delivery technologies desired.
• Microsoft Office Suite software proficiency required.
• Demonstrated execution of product development activities with a multi-disciplinary team from user-need identification and concept ideation through feasibility, verification, validation, design transfer, or commercialization; regulated medical device experience strongly preferred and experience supporting design control documentation is expected.
• Working knowledge of engineering drawings, tolerancing, and ASME GD&T standards preferred.
• Demonstrated understanding of relevant manufacturing processes and material science for new product development; experience with coatings, polymer processing, additive manufacturing, or implantable materials is desired.
• Working knowledge of FDA Quality System Requirements, EU MDR, design controls, risk management, and recognized medical device standards required; familiarity with drug-device combination products is desired.
• Demonstrated working knowledge of statistics applied to engineering studies, including sample size rationale, design of experiments, and hypothesis testing; Minitab experience desired.
• Experience evaluating early-stage or externally developed technologies, including technical feasibility, development risks, and test strategy, is desired especially for infection prevention, infection treatment, biomaterials, coatings, or local delivery applications.

Your Background

• Minimum Requirements: Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent experience. 
• Degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Biomedical Engineering, Bioengineering, Materials Science or Materials Engineering, Chemical Engineering, Polymer Engineering, or a related engineering discipline highly preferred.
• 3-5 years of full-time engineering experience in regulated medical device product development highly preferred.
• Experience with orthopedic implants, biomaterials, antimicrobial technologies, wound management, coatings, or local drug delivery is strongly preferred.

Travel Expectations

Up to 5%

Expected Compensation Range

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