Title: Design Quality Engineer Software Focus
Location: MA
Duration: 6 months initially, with potential for extension.
Pay Rate: $48/hr - $52/hr on W2 Max
Job Description
We are seeking a Design Quality Engineer to support medical device development and sustaining projects, with a primary focus on product software. The engineer will help maintain design controls and risk management documentation, review software requirements and verification/validation evidence, and support traceability and Design History File (DHF) completeness. The role will work with R&D, Manufacturing, Regulatory, and Project Management to assess design changes, resolve quality issues, and support design transfer and regulatory submission readiness. The ideal candidate can take ownership of assigned work in a fast-paced environment, identify documentation gaps, and communicate clearly across functions.
Qualifications
Medical Device Software Quality: Direct experience supporting design quality or design assurance for software used in a regulated medical device.
Design Controls and DHF: Experience reviewing design inputs/outputs, design documentation, and DHF records across development or sustaining projects.
Software Verification and Validation: Experience reviewing software test protocols, results, and requirements-to-test traceability, and identifying gaps or unresolved issues.
Risk Management: Experience with medical device risk assessments and FMEAs, including evaluating the effect of software or design changes on device safety and performance.
Change Control and Quality Investigations: Ability to assess design change impacts and support related documentation, investigations, CAPA, and design transfer activities.
Regulated Development: Working knowledge of medical device design controls and quality/risk management processes, including FDA requirements, ISO 13485, and ISO 14971.
Communication and Execution: Ability to work independently, manage multiple priorities, follow through on commitments, and communicate progress and availability consistently.
Benefits: This a contract position 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