Design Quality Engineer (Medical Device)

Job Title: Design Quality Engineer – Software Quality, SiMD & SaMD

Location: Massachusetts

Duration: 6 months initially, with potential for extension

Job Description

We are seeking an experienced Design Quality Engineer with a strong background in medical device software quality, Quality Management Systems (QMS), and Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD). The consultant will support Design Quality Engineering activities for the development of remote software and mobile applications. In addition they will support the development, improvement, and implementation of software-related quality procedures as the organization expands its medical device software capabilities. This role will work with R&D, Regulatory, and Project Management to assess design changes, resolve quality issues, and support design transfer and regulatory submission readiness. focus heavily on Additionally throughout the design and development process, evaluating existing software quality processes, identifying compliance and documentation gaps, developing and revising SOPs, and ensuring alignment with applicable regulatory requirements. The ideal candidate will have hands-on experience supporting software quality systems, design controls, and software lifecycle processes, rather than primarily performing software verification and validation testing. This individual must be capable of independently driving quality system improvements and collaborating with cross-functional engineering, quality, and regulatory teams.

Qualifications

• Software QMS: Hands-on experience developing, maintaining, and improving quality management processes and procedures supporting medical device software.
• Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD): Experience supporting regulated software products, including standalone medical device software or software incorporated into medical devices.
• SOP Development: Demonstrated experience creating, revising, and implementing software-related SOPs, work instructions, and quality procedures.
• QMS Gap Assessments: Ability to evaluate existing software quality processes, identify documentation and compliance gaps, and implement improvements.
• Software Design Controls: Experience with software design inputs/outputs, requirements traceability, design reviews, and Design History File (DHF) documentation.
• Software Development Lifecycle: Strong understanding of software development processes and associated quality requirements.
• Regulatory Compliance: Working knowledge of FDA medical device quality requirements, ISO 13485, and ISO 14971. Experience with IEC 62304 is preferred.
• Software Verification & Validation: Experience reviewing software V&V documentation, test protocols, and traceability to ensure regulatory compliance.
• Risk Management and Change Control: Experience supporting software risk assessments, design changes, and quality investigations.