Design Quality Engineer - Medical Devices

Title: Design Quality Engineer

Duration: 12 Months (Potential to get extension)

Location: Remote

Summary:

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.

Essential Duties & 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.
• Occasional travel may be required to support product development activities, supplier visits, or audits.
• Interaction:
• The incumbent works closely with various departments (e.g., QC, QA, Operations, Regulatory and within R&D).

Education and Experience:

· BS Degree or higher in engineering field required (e.g., Electrical, Systems, Mechanical engineering)

· Experience with design, sustaining engineering, or medical device quality engineering required

· Minimum 3 years experience in design, sustaining engineering, or medical device quality engineering required

Knowledge, Skills, and Abilities:

· 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 escalate issues appropriately