Product Sustaining Engineer
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Paragon 28, Inc.
Fort Collins, CO, US
Summary
Lead design engineering projects and optimize legacy product lines for extremity orthopedics. Manage design history files, engineering change requests, and participate in root cause analysis and testing protocols.
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.
- 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.
EOE
Paragon 28, a Zimmer Biomet Company, was established in 2010 as an orthopedic foot and ankle company. The name “Paragon 28” was chosen to show that we are exclusively a foot and ankle company, with the “28” representing the number of bones in the foot. We will remain true to that vision. Paragon 28 was started as a small, family-based company and we have kept those core ideals as we have grown.
Our mission is to strategically build a company around the core principles that drive innovation and quality. Relentlessly working to advance the science behind foot and ankle surgery, Paragon 28 is passionate about and committed to:
- Creation and Innovation: Blending different surgical philosophies from various global thought leaders to develop bio-mechanically and clinically relevant surgical solutions.
- A Focus on Service: A customer service based, dedicated, and highly trained distribution network to the foot and ankle market.
- Efficient Practices: Meeting the needs of increasing pricing pressures and reimbursement while continuing to develop cutting-edge surgical implants.
- Practical and Comprehensive Solutions: Creating complete surgeon-centric systems, specialty instruments, and next generation implants to solve real world issues faced by foot and ankle surgeons.
- Research Motivated: Improving clinical outcomes through meaningful and unbiased research. We are ready to embrace research data regardless of marketing impact.
Motivation, competition and the desire to learn are unique characteristics that are incredibly valuable to our success. Paragon 28’s work environment is modern and exciting. We are seeking experienced and energetic individuals to join our team in areas of Quality, Engineering, Marketing, Sales, Administration and Accounting.
Founded
2010
Company size
51-200 employees
Industry
Medical Equipment Manufacturing
Org type
Public Company
Headquarters
Englewood, Colorado
Paragon 28, a Zimmer Biomet Company, was established in 2010 as an orthopedic foot and ankle company. The name “Paragon 28” was chosen to show that we are exclusively a foot and ankle company, with the “28” representing the number of bones in the foot. We will remain true to that vision. Paragon 28 was started as a small, family-based company and we have kept those core ideals as we have grown.
Our mission is to strategically build a company around the core principles that drive innovation and quality. Relentlessly working to advance the science behind foot and ankle surgery, Paragon 28 is passionate about and committed to:
- Creation and Innovation: Blending different surgical philosophies from various global thought leaders to develop bio-mechanically and clinically relevant surgical solutions.
- A Focus on Service: A customer service based, dedicated, and highly trained distribution network to the foot and ankle market.
- Efficient Practices: Meeting the needs of increasing pricing pressures and reimbursement while continuing to develop cutting-edge surgical implants.
- Practical and Comprehensive Solutions: Creating complete surgeon-centric systems, specialty instruments, and next generation implants to solve real world issues faced by foot and ankle surgeons.
- Research Motivated: Improving clinical outcomes through meaningful and unbiased research. We are ready to embrace research data regardless of marketing impact.
Motivation, competition and the desire to learn are unique characteristics that are incredibly valuable to our success. Paragon 28’s work environment is modern and exciting. We are seeking experienced and energetic individuals to join our team in areas of Quality, Engineering, Marketing, Sales, Administration and Accounting.
Founded
2010
Company size
51-200 employees
Industry
Medical Equipment Manufacturing
Org type
Public Company
Headquarters
Englewood, Colorado