Software Quality Engineer II

Location: Remote in MA, RI, NC or CA Department: Quality Assurance Reports To: Director of Quality Position Summary We are seeking a highly organized, detail-oriented Software Quality Engineer II to join our growing team developing innovative medical imaging software and medical devices. This individual will play a key role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance throughout the software development lifecycle. As a member of a small, collaborative startup team, you will have broad responsibility and significant visibility across engineering, regulatory, clinical, and product functions. This role is ideal for someone who enjoys wearing multiple hats, taking ownership of quality processes, building scalable systems, and helping shape the quality culture of a fast-growing organization. The ideal candidate has experience supporting regulated medical device software, preferably in medical imaging or Software as a Medical Device (SaMD), and is comfortable working in a dynamic environment where priorities evolve and initiative is valued. Responsibilities

• Serve as the Software Quality Engineer on cross-functional product development teams.
• Ensure software development activities comply with ISO 13485, IEC 62304, FDA Quality System Regulation (21 CFR Part 820/QMSR), and internal quality procedures.
• Review and approve software lifecycle documentation, including software requirements, architecture, design, verification and validation documentation, risk management files, traceability matrices, and release documentation.
• Participate in software risk management activities in accordance with ISO 14971.
• Support preparation and review of documentation for FDA 510(k) submissions and other global regulatory filings.
• Review software defects, root cause investigations, CAPAs, change controls, and nonconformances.
• Help maintain and continuously improve the Quality Management System (QMS).
• Support internal and external audits, including FDA and ISO 13485 inspections.
• Partner closely with software development to integrate quality into product development while enabling efficient execution.
• Contribute to establishing scalable quality processes appropriate for a growing startup organization.

Required Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or a related technical field.
• 2 to 4 years of software quality engineering experience in the medical device industry.
• Experience with medical imaging software, DICOM, PACS, image processing, or diagnostic imaging systems.
• Working knowledge of ISO 13485, IEC 62304, ISO 14971, FDA Design Controls, FDA 510(k) submissions
• Experience reviewing software verification, validation, and traceability documentation.
• Excellent technical writing and documentation review skills.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD).
• Knowledge of FDA cybersecurity guidance for medical devices.
• Experience supporting FDA inspections or ISO 13485 certification audits.

Who You Are

• Exceptionally organized and able to manage multiple priorities without losing attention to detail.
• Naturally proactive and comfortable taking ownership with minimal direction.
• Thrives in a fast-paced startup environment where flexibility and adaptability are essential.
• Enjoys working on a small, highly collaborative team where every contribution has visible impact.
• Comfortable building processes as well as following them.
• Curious, resourceful, and motivated by solving complex quality and compliance challenges.
• Committed to producing high-quality work and maintaining inspection-ready documentation.

Benefits package includes health, dental, and vision insurance; 401(k); generous paid holiday and vacation time. To Apply Email resume and brief cover letter explaining previous SaMD QMS experience to [email hidden].