Staff Design Assurance Engineer - Remote

Overview

This position is responsible for leading Design Quality Assurance and Quality Engineering activities throughout the Product Development Lifecycle for new product development, ensuring compliance with applicable standards and regulations for medical devices.

In Short

• Lead Design Quality Assurance for medical devices.
• Ensure compliance with ISO 13485 and FDA regulations.
• Review and provide feedback on design documents and validation plans.
• Support cybersecurity risk management for medical devices.
• Collaborate with project management for continuous improvement.
• Guide the generation of design control documentation.
• Maintain effective communication with software engineers.
• Organize and manage large documentation sets.
• Implement effective Design Control Systems.
• Work in a fast-paced environment with multiple responsibilities.

Requirements

• BS degree in engineering/science/computer systems/quality management.
• 7+ years of experience in Systems or Software Design Quality Engineering.
• Experience with FDA and ISO regulated environments.
• Knowledge of IEC 62304, ISO 14971, and related standards.
• Experience with software development lifecycles.
• Strong analytical and problem-solving skills.
• Ability to prioritize projects in a fast-paced environment.
• Proficiency in Microsoft Office Tools.
• ASQ, CSQE or other software quality certifications are a plus.
• Experience with Agile methodology is beneficial.

Benefits

• 100% remote working arrangements available.
• Competitive salary range based on experience.
• Opportunities for professional development.
• Collaborative work environment.
• Support for a healthy work-life balance.