Product Sustaining Engineer (12193)

Paragon 28, a Zimmer Biomet company , is rewriting the playbook for foot and ankle orthopedic innovation. We are looking for a driven engineer to join our Product Sustaining team onsite in Englewood, CO.

The Mission: Lead design engineering projects, support and optimize our legacy product lines, and help build the future of extremity orthopedics.

The Vibe: The agility and focus of a dedicated extremity leader, backed by the powerhouse global resources of Zimmer Biomet.

This is a hybrid position with weekly onsite presence at our Englewood, Colorado location.

Produce deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff including: Review and evaluate product non-conformances for incoming legacy product 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. 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 Participate in activities related to project phase gate design reviews Assist with 3rd party suppliers, contractors, testing houses, etc. Assist in inspection of current and newly developed medical devices

Review and evaluate product non-conformances for incoming legacy product

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.

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

Participate in activities related to project phase gate design reviews

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

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

Upto 10% travel required.