Design Quality Engineer I

About the role

The Design Quality Engineer supports robust and compliant design control practices for the iovera product line. Working within cross‑functional teams, the role ensures regulatory compliance and quality throughout product development and the product lifecycle.

Key responsibilities

• Collaborate with R&D and cross‑functional teams to meet design control requirements during development and lifecycle management.
• Support design verification, validation, risk management, and design reviews to satisfy safety, performance, and regulatory standards.
• Review engineering design changes, providing quality input on documentation, traceability, and risk assessment.
• Participate in sustaining engineering projects, ensuring ongoing compliance and product improvements.
• Handle complaint data, conduct root‑cause analysis, and identify design‑related trends.
• Prepare quality deliverables for regulatory submissions such as 510(k)s and technical documentation.
• Support internal and external audits by providing design history and risk management records.
• Track quality metrics and contribute to management review inputs related to design control and product performance.

Required profile

• BS degree or higher in an engineering discipline (e.g., Electrical, Mechanical, Systems).
• 1‑2 years of experience in design, sustaining engineering, or medical device quality engineering.
• Advanced English proficiency.
• Willingness to travel up to 40% for product development, supplier visits, or audits.

Required skills

• Working knowledge of ISO 13485, 21 CFR 820, and EU MDR.
• Experience with design controls and risk management.
• Statistical knowledge and understanding of measurement uncertainty.
• Intermediate proficiency with Microsoft Excel.

What we offer

• Development opportunities and robust employee resource groups (ERGs).
• Flexible working environment and location‑specific competitive total rewards.
• Wellness incentives and a culture of recognition and performance awards.