Design Quality Engineer II

The Engineer II, Design Quality will support design quality and sustaining engineering activities for medical device products. This role will assist with design controls, design quality documentation, sustaining product changes, design change assessments, DHF updates, risk management documentation, V&V documentation review, and cross-functional support with R&D, Quality, Regulatory, Manufacturing, and Sustaining Engineering teams.

This is a more junior/mid-level role compared to a Senior Design Quality Assurance Engineer. The ideal candidate should have hands‑on experience supporting design quality activities in a regulated medical device environment and be comfortable working under the direction of senior quality, engineering, or project leadership.

• Support sustaining engineering activities for released medical device products.
• Assist with product design changes, documentation updates, and released product improvements.
• Support change impact assessments for sustaining engineering projects, including impacts to DHF, DMR, V&V, risk files, labeling, specifications, and released documentation.
• Review and support engineering change orders, document revisions, and quality records.
• Partner with Sustaining Engineering, R&D, Quality, Regulatory, Manufacturing, and Document Control to support product updates and compliance.
• Support investigations related to product quality issues, design‑related nonconformances, complaints, CAPA, or field feedback as needed.
• Help ensure sustaining changes remain compliant with FDA 21 CFR 820, ISO 13485, ISO 14971, and internal procedures.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of experience in medical device quality, design assurance, design controls, or related engineering quality support.
• Familiarity with FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Experience supporting DHF documentation, design changes, V&V documentation, risk management, or quality system documentation.
• Strong attention to detail and ability to work in a regulated documentation environment.
• Ability to collaborate cross‑functionally with engineering, quality, regulatory, manufacturing, and document control teams.
• Strong written and verbal communication skills.

• Experience with catheter‑based, cardiovascular, electromechanical, or other medical device products.
• Experience supporting sustaining engineering, released product changes, engineering change orders, design changes, or product lifecycle documentation in a regulated medical device environment.
• Experience with PLM/eQMS tools such as Agile, Windchill, Arena, Track Wise, Master Control, or similar systems.
• Experience supporting remediation, audit readiness, CAPA, NCR, or DHF documentation updates.
• Prior experience working in a fast‑paced project or sustaining engineering environment.