Product Sustaining 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 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

Paragon 28, a Zimmer Biomet Company, is hiring a Product Sustaining Engineer for our team in Englewood, Colorado. The Product Sustaining Engineer has responsibility for leading projects that support legacy product systems and design and development of medical devices. This will be a hybrid position requiring onsite work at our Englewood, Colorado location.

How You'll Create Impact
Essential Responsibilities and Duties

• Produce deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff including: o Review and evaluate product non-conformances for incoming legacy product o Review and evaluate product complaints
• Update designs and device specifications for legacy products
• Conceptualize new design ideas for legacy product systems and new development projects or line extensions
• Use SolidWorks for parametric modeling and detailing designs of P28 implants and instruments
• Create or update design control documentation for P28 design history files & technical files. o Create Engineering Change Requests (ECR) and manage through completion.
• Ownership of development related CAPAs. Participation in root cause analysis to investigate issues.
• Assist in documentation remediation efforts including: DHF documentation, risk documentation, inspection plans, protocols and reports.
• Development of testing protocols and testing process for new and existing products o Participate in activities related to project phase gate design reviews o Assist with 3rd party suppliers, contractors, testing houses, etc.
• Assist in inspection of current and newly developed medical devices
• Observe surgery (live, cadaver, or video) on lower extremity pathology. Document all notes.

Participates in cadaveric labs to support assigned projects.

• Other duties as directed by manager

Your Background
Qualifications

• Requires a bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 2-5 years of experience.
• Prior experience in medical device development helpful.
• Understanding of medical device industry regulatory requirements preferred.
• Experience with CAD. SolidWorks preferred.
• 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, where lab safety must be adhered to.

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 is required to have close visual acuity to perform activities such as: viewing a computer terminal and design drawings as well as visual inspection involving small parts. The employee frequently is required to move about the facility. 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

10% of overnight travel

Compensation Data

Salary Range: $70,000 - $90,000 USD annually depending on skills and experience

Physical Requirements

EOE

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