Development Sr Engineer I

The Development Sr Engineer I at Zimmer Biomet is responsible for supporting new product design, development, and commercialisation of innovative medical devices, particularly in the orthopaedic field. The role involves collaborating with cross-functional teams, ensuring compliance with global regulatory standards, and managing project timelines and resources. Candidates must have a Bachelor’s degree in Engineering and at least 3 years of relevant experience, with proficiency in Microsoft Office Suite and knowledge of ASME GD&T standards. Experience with manufacturing processes, material science, and regulatory requirements is essential. The position is hybrid, requiring 4 days onsite per week, and offers an annual compensation range of $80,000–$100,000 USD. Preferred qualifications include experience with Ansys, NX Unigraphics, and advanced CAD modelling.

The Development Sr Engineer I at Zimmer Biomet plays a pivotal role in supporting new product design, development, and commercialisation within the medical device sector. This position is responsible for translating user needs into innovative product solutions, ensuring compliance with global regulatory standards, and contributing to the company’s mission of enhancing patient mobility worldwide. The role involves close collaboration with cross-functional teams, regulatory affairs, and clinical affairs to deliver high-quality products. Compensation for this role ranges from $80,000 to $100,000 USD annually, with additional benefits such as wellness incentives, competitive rewards, and a culture of recognition. The position is hybrid, requiring four days onsite per week.

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

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.

This position is hyrbid, 4 days onsite per week.

How You'll Create Impact

• Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards
• 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 which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards
• 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 to ensure appropriate quality control inspection plans are generated
• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing 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 test methods and/or predictive modeling as required to evaluate new products, and complete test method validation as required by Zimmer Biomet procedures and global regulatory requirements
• Authors, reviews, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Zimmer Biomet procedures and global regulatory requirements
• 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
• Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations
• May serve as a project manager for small scale, lower technical complexity projects for new product development, market released product manufacturing/sourcing transfers and/or market released product design changes
• Creates, manages and communicates project timelines, budgets and resource plans to stakeholders as directed by supervisor
• Anticipates and seeks approval for incremental resources as needed
• Schedules and coordinates project team meetings
• Coordinates, assigns to project team members and tracks project tasks to timeline
• Communicates project status to leadership in designated reoccurring meetings
• Identifies anticipated project risks, determines appropriate contingency plan(s) with stakeholder and project team member input, communicates risks in appropriate status update meetings and obtains supervisor approval to implement contingency plans

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 good written and verbal communication skills, able to deliver professional communications to a global audience base
• 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
• Microsoft Office Suite software proficiency required
• Working knowledge of ASME GD&T standards with application to product design required
• Design for Six Sigma experience desired
• Parametric CAD modeling experience preferred; NX Unigraphics Software Proficiency desired
• Finite element analysis predicative modeling experience desired
• 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
• 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
• Ansys Software proficiency desired

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 equivalent) in Mechanical, Biomedical or Industrial Engineering highly preferred
• 3-5 years or more of full-time engineering experience highly preferred

Travel Expectations

Up to 10%

Expected Compensation Range

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

EOE

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

Responsibilities:

• Responsible for staying current with relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• Play a key role in shaping product designs that address targeted user needs and author design rationale for all features.
• Help drive innovation in new product design, development, and commercialisation, including preparation and review of invention disclosures and patents.
• Take ownership of coordinating with cross-functional team members in the production and inspection of product prototypes and final design verification.
• Deliver high-quality product production specifications that account for manufacturability, process capability, and inspection.
• Collaborate cross-functionally to identify and document critical quality product features and ensure appropriate quality control inspection plans.
• Lead efforts to evaluate, verify, and validate product designs in compliance with Zimmer Biomet procedures and global regulatory requirements.
• Support Zimmer Biomet Quality, Sourcing, and Manufacturing teams with new product design transfer tasks and test method validation.
• Support Regulatory Affairs with the creation of regulatory submission documentation and clinical study plans for new and market released products.

Skills:

• Demonstrated good written and verbal communication skills, with the ability to deliver professional communications to a global audience.
• Understanding of various manufacturing processes such as subtractive machining, anodisation, additive manufacturing, forging, casting, and plastic moulding, as well as material science for new product development.
• Familiarity with FDA QSR and EU MDR medical device regulatory requirements and recognised technical product standards, with global medical device regulatory requirements knowledge preferred.
• Proficiency in Microsoft Office Suite is required.
• Working knowledge of ASME GD&T standards with application to product design is required.
• Experience with Design for Six Sigma is desired.
• Parametric CAD modelling experience and proficiency with NX Unigraphics Software are desired.
• Experience with finite element analysis and predictive modelling is desired.
• Ansys Software proficiency is desired.
• Demonstrated product design and development execution with a multi-disciplinary project team from user need identification through commercialisation is desired.

Education:

• A Bachelor's Degree in Engineering is required.
• A degree from an ABET accredited school (or equivalent) in Mechanical, Biomedical, or Industrial Engineering is highly preferred.