Product Sustaining Engineer

Merck KGaA Darmstadt Germany • Broomfield, CO

237d

About The Position

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. The Product Sustaining Engineer has responsibility for leading projects that support legacy product systems and design and development of medical devices.

Requirements

• Requires a bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline.
• 2-5 years of experience in a related field.
• 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.

Nice To Haves

• Technical Proficiency (Specific to Orthopedics)
• Knowledge of Medical Device Design Controls
• Problem-Solving and Innovation examples of creative problem-solving—solving a clinical need, optimizing a design, or troubleshooting failure modes.
• Strong Cross-Functional Communication Skills.

Responsibilities

• Produce deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff.
• 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 and document all notes.
• Participates in cadaveric labs to support assigned projects.
• Other duties as directed by manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree