Design Quality Engineer II

Vanguard Solutions, Inc; Carlsbad (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Vanguard Solutions, Inc. is seeking an Engineer II, Design Quality to support design quality and sustaining engineering activities for medical device products in a regulated environment.

The role covers design controls, DHF updates, risk management documentation, V&V documentation review, and cross-functional collaboration with R&D, Quality, Regulatory, Manufacturing, and Document Control. The ideal candidate will have a hands-on background in medical device quality, be comfortable working under

Qualifications

• 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 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.

Responsibilities

• 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 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.

Skills

Attention to detail

Cross-functional collaboration

Verbal communication

Written communication

Regulatory understanding

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Agile PLM

Windchill

Arena

TrackWise

MasterControl

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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, TrackWise, MasterControl, 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.