Product Sustaining Engineer

Zimmer Biomet; Westminster (CO); Hybrid; USD 75,000 - 100,000; Full time

Job summary

Zimmer Biomet, Paragon 28 is seeking a driven engineer to join the Product Sustaining team onsite in Englewood, CO. This hybrid role requires CAD proficiency, SolidWorks experience, and 2–5 years in medical devices.

You will review product non-conformances, update designs and specs, and support design history files and change requests. Travel and collaboration across teams are expected.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 2–5 years of engineering experience, preferably in medical devices.
• Knowledge of medical device regulations preferred.
• Experience with CAD; SolidWorks preferred.
• Strong MS Office and communication skills.

Responsibilities

• Produce sustaining engineering deliverables for legacy products.
• Review non-conformances and product complaints.
• Update designs and specifications for legacy devices.
• Create and manage design history files and change requests.
• Assist with testing, validation, and inspection activities.

Skills

CAD

SolidWorks

MS Office

Teamwork

Communication

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

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 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.

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.

EOE