Zimmer Biomet

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

The Sr. Product Development Engineer leads the design of new products and improvements to existing products and systems, as part of a project team. This role also develops new product designs with firm grasp on design for manufacturing and customer need. This position is located in Englewood, Colorado at Paragon 28, a Zimmer Biomet Company focusing on orthopedic medical devices for the foot and ankle.

How You'll Create Impact

Essential Responsibilities and Duties

• Lead product development efforts from ideation to commercialization through entire product life cycle, as part of a team, including:
• Research and evaluate products, parts, processes for efficiency and reliability
• Conceptualization of new design ideas while understanding the inadequacy of existing designs.
• Parametric modeling and detail design of P28 implant and instrument development with a firm grasp on design for manufacturing
• Assist junior Engineering staff with modeling and detailing methodology
• Lead efforts of new product development in design control, including the management and implementation of P28 design history files.
• Lead design efforts to minimize patient risk and adhere to regulatory requirements
• Lead in development of testing protocols and assist in the testing process for new and existing products
• Analyze test results and recommend appropriate design changes
• Formulate complete test strategies and test reports with R&D and regulatory. Work with Marketing to determine how data or analysis could be used for education or as selling tool in abstract/poster or white paper.
• Interface with 3rd party suppliers, contractors, testing houses, etc.
• Assist the P28 Quality and Supply Chain departments to evaluate new suppliers for inclusion in the P28 approved supplier list
• Assist P28 Quality team in developing inspection plans
• Aide in publication efforts with Clinical Affairs team.
• Lead surgical demonstrations (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions.
• Provide sales support via phone and live training as “expert” technical resource within specific product categories.
• Compile invention disclosures for patent applications and infringement evaluations
• Participate in root cause analysis and corrective action development for design related issues in released product
• Assist with other development projects as additional resource when needed, while balancing own workload
• Other duties as directed by manager

Non – Essential Responsibilities and Duties

• Participate in clinical research projects or clinical trials.
• Assist/ aide in skills development of junior engineers including:
• Design for manufacturing
• Develop testing strategies
• Implementation of design control documentation
• Validation and verification planning

Your Background

• Requires a bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 6+ years of experience
• Prior experience in medical device development required.
• Prior experience in taking a medical device or similar product from ideation to commercialization required.
• Ability to read and interpret documents such as drawings, engineering specifications, testing standards, regulatory guidance documents, safety rules, company policy and procedure manuals.
• Demonstrated ability to lead projects l autonomously as part of a cross-functional team (Supply Chain, Marketing, Quality, Regulatory, etc.) and deliver updates to senior management.
• Experience with designing for manufacturability, inspection and assembly.
• Proficient with design control activities and verification and validation activities with respect to medical device development.
• Understanding of medical device industry regulatory requirements required.
• Proficient with CAD. Solidworks preferred.
• High proficiency in MS Office
• Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers
• Ability to work in a team environment

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and copy machines. Occasional use of the development and quality labs necessary, adhering to all lab safety requirements. This position will work with cadaveric specimens.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee frequently is required to move about the facility. The employee is required to have close visual acuity to perform activities such as inspecting small parts, viewing computer terminal and drawings. The employee may be required to lift up-to 35 lbs. by themselves.

Position Type/Expected Hours of Work

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.

Travel Expectations

Up to 15% of overnight travel.

Compensation Data

Expected Salary Range: $93,000 - $125,000 USD annually

EOE