Design Quality Engineer I

Zimmer Biomet; Bogotá ciudad; On-site; COP 60,000,000 - 90,000,000; Full time

Job summary

Zimmer Biomet seeks a Design Quality Engineer to drive design control compliance across new product development and sustaining engineering for the iovera line. You will serve as a quality representative on cross‑functional teams, supporting regulatory requirements and internal standards.

The role emphasizes design changes, risk management, documentation, and continuous improvement throughout the product lifecycle, with strong collaboration across R&D, Regulatory, Operations, and Quality

Qualifications

• BS degree or higher in engineering (Electrical, Systems, Mechanical, Bio medical)
• Experience with design, sustaining engineering, or medical device quality engineering
• Minimum 1-2 years’ experience in design, sustaining engineering, or medical device quality engineering
• Strong knowledge of Design Controls and Risk Management
• Advanced Excel skills; Advanced English communication

Responsibilities

• Collaborate with R&D and cross-functional teams to support design control requirements throughout product development and lifecycle management.
• Support design verification and validation, risk management, and design reviews to help ensure applicable safety, performance, and regulatory requirements are met.
• Review engineering design changes and provide quality input to ensure appropriate documentation, traceability, and risk assessment.
• Support continuous improvement of design control processes, templates, and procedures to align with regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality support to maintain compliance and support product improvements.
• Support complaint handling by reviewing complaint data, participating in root cause analysis, and identifying design‑related trends or failure modes.
• Assist in preparing quality deliverables for regulatory submissions, including 510(k)s, technical documentation, and IDE‑related documentation.
• Support internal and external audits by preparing relevant design history and risk management documentation.
• Collaborate with Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to support consistent approaches to design quality.
• Support quality metric tracking and management review inputs related to design control and product quality performance.
• Perform other quality‑related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.

Skills

Design Controls

Risk Management

Statistical Analysis

Measurement Uncertainty

Regulatory Knowledge

Excel

English Proficiency

Cross-functional Collaboration

Quality Assurance

Data Analysis

Education

Bachelor's in Engineering

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 Design Quality Engineer will support robust and compliant design control practices across new product development and sustaining engineering activities for the iovera product line. This role serves as a quality representative within cross-functional teams, supporting compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485, EU MDR) and internal quality standards. The Design Quality Engineer will support design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle.

How You'll Create Impact

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Collaborate with R&D and cross-functional teams to support design control requirements throughout product development and lifecycle management.
• Support design verification and validation, risk management, and design reviews to help ensure applicable safety, performance, and regulatory requirements are met.
• Review engineering design changes and provide quality input to ensure appropriate documentation, traceability, and risk assessment.
• Support continuous improvement of design control processes, templates, and procedures to align with regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality support to maintain compliance and support product improvements.
• Support complaint handling by reviewing complaint data, participating in root cause analysis, and identifying design‑related trends or failure modes.
• Assist in preparing quality deliverables for regulatory submissions, including 510(k)s, technical documentation, and IDE‑related documentation.
• Support internal and external audits by preparing relevant design history and risk management documentation.
• Collaborate with Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to support consistent approaches to design quality.
• Support quality metric tracking and management review inputs related to design control and product quality performance.
• Perform other quality‑related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.

What Makes You Stand Out

• Working knowledge of ISO 13485, 21 CFR 820, EU MDR
• Experience with Design Controls and risk management
• Statistical knowledge and understanding of measurement uncertainty
• Detail oriented, well organized and have excellent communication skills
• Able to accomplish objectives with general supervision and eliminate issues appropriately

Your Background

• BS Degree or higher in engineering field required (e.g., Electrical, Systems, Mechanical,Bio medical, engineering)
• Experience with design, sustaining engineering, or medical device quality engineering required
• Minimum 1-2 years’ experience in design, sustaining engineering, or medical device quality engineering required
• Knowledge of basic regulations applicable to manufacturing in the United States.
• Understanding of regulatory requirements, product registrations, compliance activities, and audit processes.
• Ability to apply scientific principles and creative problem-solving to engineering challenges.
• Strong knowledge of Design Controls and Risk Management, particularly related to electronic device design.
• Experience with statistical analysis and statistical techniques.
• Evaluate, implement, and validate design changes to existing products.
• Collaborate closely with engineers to support product development workflows and processes.
• Support the transfer of products and processes into manufacturing and supplier environments.
• Apply scientific rationale and technical logic to support development strategies and decision‑making.
• Advanced Excel skills, including data analysis and reporting.
• Advanced English communication skills, both written and verbal.

Travel Expectations

Yes, 40%. Occasional travel may be required to support product development activities, supplier visits, or audits.

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