Product Sustaining Engineer II

Zimmer Biomet; Englewood (CO); On-site; USD 80,000 - 100,000; Full time

Job summary

Zimmer Biomet seeks a Product Sustaining Engineer II in Englewood, CO to lead sustaining activities for legacy products post-launch. You will review non-conformances, support global registrations, create and manage ECRs, CAPAs, and update device specs. A BS in Mechanical or Biomedical Engineering with 3+ years in medical devices is required; CAD (SolidWorks) and MS Office skills are expected. Travel up to 10%. Salary $80k–$100k. Excellent communication and teamwork required.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• Minimum 3 years of experience in sustaining or development of medical devices.
• Experience with CAD; SolidWorks preferred.
• Proficiency in MS Office.
• Strong communication and presentation skills.
• Ability to work in a team environment.

Responsibilities

• Holds a leading role in sustaining activities for legacy product systems, as directed by senior staff.
• Review and evaluation of product non-conformances for incoming legacy product.
• Review and evaluation of product complaints.
• Support regulatory registrations and design history files.
• Create and manage Engineering Change Requests (ECRs).
• Lead root cause analysis for CAPA development.
• Update designs and specifications for legacy products.
• Develop testing protocols for product evaluations.
• Participate in phase gate design reviews and cross-functional activities.
• Collaborate with 3rd party suppliers and testing houses.

Skills

Effective communication

Presentation skills

Teamwork

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

CAD

SolidWorks

MS Office

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 talent 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 included, respected, empowered and recognised.

What You Can Expect

The Product Sustaining Engineer II takes a leading role on projects that support legacy product systems. These are meaningful projects that focus on supporting legacy products in the post launch life cycle with increasing levels of autonomy.

How You'll Create Impact

• Holds a leading role in the production of deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff including:
  • Review and evaluation of product non-conformances for incoming legacy product
  • Review and evaluation of product complaints
  • Post launch global registration sequences and support regulatory team according to priority.
  • Creation of post-launch documentation to support global registrations design control documentation for P28 design history files & technical files.
  • Documentation remediation efforts including: DHF documentation, risk documentation, inspection plans, protocols and reports.
  • Create Engineering Change Requests (ECR) and manage through completion.
  • Development related CAPAs; lead in root cause analysis to investigate issues.
  • Update designs and device specifications for legacy products
  • Development of testing protocols and testing process for product evaluations
  • Participate in activities related to project timelines for sustaining activities (i.e. Smartsheet)
  • Participate in activities related to project phase gate design reviews for projects requiring phase gate reviews.
  • Participate in discussions with 3rd party suppliers, contractors, testing houses, etc.
  • Inspection of current and newly developed medical devices; update inspection plans as necessary.
• May mentor junior Engineers
• Other duties as directed by manager

Your Background

• Requires a bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with a minimum of 3 years of experience.
• Prior experience in the sustaining or development of medical devices preferred.
• 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

10% overnight travel

Compensation Data

Salary Range: $80,000 - $100,000 USD Annually

EOE/M/F/Vet/Disability