Design Quality Engineer

Title : Design Quality Engineer Software Focus

Location: Massachusetts

Employment Type: Contract W2

Duration: 6 Months initially, with potential for extension

About the Role

We are seeking a Design Quality Engineer with a strong software quality focus to support medical device development and sustaining projects. The role will support Design Controls, risk management, software verification/validation, traceability, and Design History File (DHF) activities.

Responsibilities

• Support Design Quality and Design Assurance activities for software used in regulated medical devices.
• Review design inputs, outputs, design documentation, and DHF records.
• Review software requirements, verification/validation protocols, test results, and requirements-to-test traceability.
• Identify documentation gaps, quality issues, and unresolved verification/validation activities.
• Support medical device risk assessments, FMEAs, and evaluation of software/design changes.
• Assess design change impacts and support change controls, investigations, CAPA, and design transfer activities.
• Support regulatory submission readiness and compliance activities.
• Collaborate with R&D, Manufacturing, Regulatory, and Project Management teams.
• Manage assigned activities independently while maintaining priorities and project timelines.

Required Qualifications

• Direct experience in Medical Device Software Quality, Design Quality, or Design Assurance.
• Experience with Design Controls and DHF documentation.
• Hands-on experience reviewing software requirements, verification/validation documentation, and traceability.
• Experience with medical device risk management and FMEA.
• Experience supporting design changes, change control, quality investigations, CAPA, and design transfer.
• Working knowledge of FDA requirements, ISO 13485, and ISO 14971.
• Strong analytical, organizational, written, and verbal communication skills.
• Ability to work independently and manage multiple priorities.

Salary

The hourly rate for this position is $48 $52/hr W2 ( DOE )

Benefits:
This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:
Background checks may be conducted in accordance with applicable law.

Work Authorization:
Applicants must be authorized to work in the United States.