Senior Software Quality Engineer (Medical Device)

Meet Life Sciences Ltd.; San Francisco (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. seeks a Senior Software Quality Engineer to drive quality across the product lifecycle in a fast-growing, early-stage environment. You will collaborate with software, systems, and hardware teams to ensure robust quality processes and regulatory readiness.

The role focuses on design quality, DHF governance, risk management and CAPA execution, with ownership of QMS activities and improving software verification and validation practices.

Qualifications

• Bachelor's or Master's in a relevant technical field.
• 8+ years in quality engineering or medical-device development.
• Experience in regulated medical-device environments.
• Strong knowledge of FDA requirements and ISO/IEC standards (13485, 62304, 14971).
• Hands-on V&V, traceability and design controls.
• Experience with AI/ML-enabled SaMD is a plus.

Responsibilities

• Support QMS implementation aligned with FDA QMSR and ISO standards.
• Develop and maintain Design History Files (DHF) with software requirements, traceability and validation documentation.
• Lead risk-management activities (FMEA, hazard analysis) per ISO 14971.
• Oversee software verification and validation activities across the product lifecycle.
• Lead computerized system assurance and validation for software tools.
• Collaborate with suppliers on design transfer and supplier quality.
• Support audits and CAPA processes; drive continuous improvement.
• Promote a quality-first culture across engineering and business teams.

Skills

Regulatory compliance

Risk management

V&V testing

Cross-functional collaboration

Problem solving

Audit readiness

CAPA handling

Education

Bachelor's or Master's degree in Biomedical Engineering, Computer Science, Electrical Engineering or related

Tools

eQMS

FMEA tools

Cybersecurity documentation tools

Job description

Join an innovative, early-stage startup developing advanced brain-computer interface (BCI) technology designed to restore independence for people living with disabilities and improve quality of life. Combining cutting-edge hardware and AI technologies, the company is working at the forefront of medical-device innovation.

The Opportunity

We are seeking a Senior Software Quality Engineer to play a key role in developing and maintaining quality standards across the product development lifecycle. Working closely with software, systems and hardware engineering teams, you will champion design quality assurance, ensure regulatory compliance and help establish robust quality processes as the company continues to grow.

This is a hands-on, cross-functional role offering significant ownership and the opportunity to influence product quality, design controls and quality-system implementation within a fast-paced, early-stage environment.

Key Responsibilities

• Support the implementation and continuous improvement of the Quality Management System (QMS), ensuring alignment with FDA QMSR, ISO 13485, IEC 62304, IEC 62366-1 and other applicable medical-device standards.
• Partner with engineering teams to develop and maintain Design History Files (DHFs), including software requirements, architecture and design specifications, verification and validation documentation, risk-management files, cybersecurity documentation and traceability matrices.
• Lead and support risk-management activities, including Failure Mode and Effects Analysis (FMEA), hazard analysis and risk assessments in accordance with ISO 14971.
• Oversee software verification and validation activities, ensuring appropriate testing, documentation and traceability throughout the product development lifecycle.
• Lead computerized system assurance and validation activities for software tools and systems used in product development and quality processes.
• Collaborate with suppliers and cross-functional teams to support design development, supplier quality and design-transfer activities.
• Support internal and external audits, ensuring relevant documentation and objective evidence are available to demonstrate compliance.
• Contribute to root-cause investigations, nonconformance management, corrective and preventive actions (CAPAs) and ongoing issue resolution.
• Support management reviews, quality-data analysis and continuous improvement initiatives.
• Promote a strong quality culture, working collaboratively with engineering and other stakeholders to integrate quality into product design and development.

Requirements

• Bachelor's or Master's degree in Biomedical Engineering, Computer Science, Electrical Engineering or a related technical discipline.
• At least 8 years of experience in quality engineering or medical-device development, ideally spanning concept development through to production release.
• Proven experience working within a regulated medical-device environment.
• Strong knowledge of medical-device regulations and standards, including FDA requirements, ISO 13485, IEC 62304, ISO 14971 and IEC 62366-1.
• Hands-on experience with software verification and validation (V&V), including test documentation, traceability and design controls.
• Practical experience with risk-management methodologies, including FMEA, hazard analysis and risk assessment.
• Experience supporting design assurance and maintaining design-control documentation throughout the product lifecycle.
• Strong cross-functional collaboration skills, with the ability to work effectively across engineering, quality and external partner teams.
• Excellent analytical and problem-solving skills, with the ability to navigate ambiguity and develop practical solutions in a changing environment.
• A proactive, hands-on approach and the ability to thrive in an early-stage company.
• Experience with AI/ML-enabled medical devices or software as a medical device (SaMD).
• Familiarity with electronic Quality Management Systems (eQMS).
• Experience with cybersecurity documentation and software-related risk management.
• Exposure to supplier quality, design transfer and product development in a hardware-and-software environment.

Why Join?

• Work on innovative technology at the intersection of medical devices, software and brain-computer interfaces.
• Take ownership of quality engineering activities within a growing, technically advanced team.
• Collaborate directly with multidisciplinary engineering teams to shape product quality and regulatory readiness.
• Contribute to technology designed to make a meaningful difference in people's lives.