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.