Design Quality Engineer

Job Summary
We are seeking an experienced Design Quality Engineer to lead and support risk management activities across new product development, sustaining engineering, and continuous improvement initiatives. This role plays a critical part in ensuring compliance with global medical device regulations while driving robust risk management processes throughout the product lifecycle—from concept through commercialization and end-of-life.
The ideal candidate will bring a strong design and manufacturing background, deep expertise in risk management standards, and the ability to collaborate effectively with cross-functional and external partners in a regulated environment.

Key Responsibilities
Lead and provide expert guidance on Risk Management and Human Factors Engineering activities throughout all phases of product development and lifecycle management.
Plan, organize, execute, and report risk management activities in collaboration with cross-functional project teams.
Develop, implement, and continuously improve risk management processes, procedures, tools, and technologies.
Establish and manage key performance indicators (KPIs) and metrics to evaluate the effectiveness of risk management practices.
Conduct SWAT assessments to identify gaps and drive continuous improvement across risk management and related business processes.
Support and lead New Product Development (NPD), Sustaining Engineering, and Continuous Improvementprojects of varying complexity.
Partner with internal stakeholders and external design/development vendors to ensure timely delivery of Design and Reliability Assurance deliverables.
Provide technical support related to planning, execution, documentation, reporting, and communication of design assurance activities.
Work independently while managing priorities and resources to meet organizational goals and project timelines.

Required Qualifications & Experience
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Systems) or Science (Biology or Chemistry).
Minimum 8 years of experience in a Quality Assurance or Design Quality role within the medical device or other regulated industry.

Preferred / Nice-to-Have Skills
Familiarity with EU MDR requirements.
Conversational Spanish language skills.
Experience supporting global, cross-functional development teams.