Associate Design Quality Engineer

About the Role

The Associate Design Quality Engineer supports product development activities to ensure compliance with design control requirements and quality system procedures throughout the product lifecycle. Working closely with Engineering, Quality, Regulatory Affairs, and other cross-functional partners, this role assists with requirements management, risk management, design control documentation, and verification and validation activities. This position provides an excellent opportunity for an early-career engineer to develop expertise in medical device product development within a regulated environment.

Key Responsibilities

• Support design control activities throughout the product development lifecycle.
• Assist in the development and maintenance of Design History File (DHF) documentation.
• Help maintain traceability between customer needs, design inputs, design outputs, risk controls, verification, and validation activities.
• Participate in design reviews and cross-functional product development meetings.
• Support risk management activities, including hazard analyses, risk assessments, and risk management documentation.
• Assist in creating and maintaining requirements traceability matrices.
• Support verification and validation planning, execution, and documentation activities.
• Review engineering documentation, test protocols, and reports for completeness and compliance.
• Assist with investigations of design-related issues, test failures, and product development concerns.
• Collaborate with Engineering, Clinical, Regulatory, Operations, and Quality teams to support development programs.
• Maintain accurate and organized quality records and documentation.
• Support internal and external audits related to product development and design controls.
• Participate in continuous improvement initiatives that enhance product quality and development effectiveness.
• Develop working knowledge of FDA regulations, ISO standards, and company quality procedures.

Requirements & Tech Stack

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, Quality Engineering, Life Sciences, or a related technical field.
• 0-3 years of engineering, quality, medical device, or related experience.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a collaborative team environment.
• Proficiency with Microsoft Office applications.

Preferred

• Internship, co-op, or project experience in medical devices, robotics, healthcare technology, or other regulated industries.
• Familiarity with FDA Quality System Regulations, ISO 13485, and/or ISO 14971.
• Exposure to design controls, risk management, verification, validation, or systems engineering principles.
• Experience with technical documentation or requirements management tools.
• Interest in pursuing a career in medical device quality engineering.