Design Quality Assurance Engineer (Medtech)

TL;DR

Design Quality Assurance Engineer (Medtech): Ensuring new product designs and changes for Infection Control Consumables meet quality and regulatory requirements with an accent on regulatory impact assessment and design change governance. Focus on driving design change reviews, managing risk assessments per ISO 14971, and ensuring traceability within the Arena PLM system.

Location: Remote (Must be based in the US)

Salary: $75,280–$94,100 annually + 4% STIP

Company

Global provider of life-saving technology and solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.

What you will do

• Govern design and design change activities in accordance with FDA (21 CFR Part 820) and EU MDR requirements.
• Drive design change reviews to ensure risk assessments (ISO 14971:2019) are completed and verification/validation activities are executed.
• Define quality requirements and critical-to-quality (CTQ) attributes for components and finished goods.
• Assess and interpret the regulatory impact of design changes on technical documentation, labeling, and instructions for use.
• Serve as a Quality SME for change management within the Arena PLM system, supporting Engineering Change Orders and impact assessments.
• Support internal and external audits by providing objective evidence and rationale for design decisions.

Requirements

• Bachelor’s degree in science, engineering, or other technical areas.
• 5+ years of relevant experience in the medical device industry, including experience in Design Quality or Quality Engineering.
• Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU MDR 2017/745.
• Hands-on experience with PLM systems (Arena preferred) and familiarity with GD&T standards.
• Ability to lead cross-functional team meetings and develop matrix relationships.
• Availability for 25% travel as needed.

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off, parental, and caregiver leave.
• Wellness initiatives and Health Assistance Resources.
• Tuition reimbursement and commuter benefits.
• Fully remote work arrangement.