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.
How You'll Create Impact
- 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
- 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
- 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
Travel Expectations
Upto 10% travel required.
Compensation Data
Salary Range: $75,000-$100,000 USD annually depending on skills and experience.