Software Quality Engineer

We are looking for individuals who are

• Self-directed initiators who take ownership of their work, proactively identify opportunities for improvement, and consistently deliver high-quality results.
• Collaborative partners who build strong cross-functional relationships and effectively communicate with internal and external stakeholders.
• Analytical problem solvers who investigate root causes, evaluate data-driven solutions, and implement sustainable corrective and preventive actions.

Key Responsibilities

Design Assurance

• Support Design Assurance activities throughout the medical device product development lifecycle.
• Ensure compliance with Design Control requirements in accordance with FDA QSR/QMSR, ISO 13485, and applicable regulatory requirements.
• Support preparation, review, and maintenance of Design History File (DHF) documentation.
• Review product requirements, design outputs, verification, validation, and traceability documentation.
• Support implementation and migration of quality systems and tools (e.g., Jama, Integrity, Matrix, or equivalent).

Risk Management

• Lead and support Risk Management activities in accordance with ISO 14971.
• Develop and maintain Risk Management Files throughout product development and manufacturing transfer.
• Facilitate and review Functional Analysis, Hazard Analysis, dFMEA, pFMEA, and uFMEA.
• Support Critical Quality Attribute (CQA) identification.
• Ensure appropriate risk controls are identified, implemented, verified, and documented.
• Evaluate manufacturing and process risks and ensure effective mitigation throughout the manufacturing lifecycle.

Validation & Usability Engineering

• Support development and maintenance of Usability Engineering Files in accordance with IEC 62366-1.
• Participate in usability studies, formative evaluations, and validation activities.
• Review and approve validation protocols, reports, and statistical analyses.
• Support Design Verification, Design Validation, Process Validation, Software Validation, Computer System Validation, and Sterilization Validation activities as applicable.

Manufacturing & Supplier Quality

• Partner with Advanced Operations and Manufacturing teams during design transfer.
• Ensure manufacturing processes are capable, controlled, and compliant before product launch.
• Support supplier qualification and supplier quality strategies.
• Review supplier validations, PPAP activities, and incoming quality requirements.
• Collaborate with suppliers to ensure components and manufacturing processes meet specified quality requirements.
• Participate in supplier performance monitoring and continuous improvement initiatives.

What you need

• Bachelor’s degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related engineering discipline.
• Minimum 5-7 years of experience in Quality Engineering, Design Assurance, or Product Development within the medical device industry.
• Experience supporting New Product Development (NPD) in a medical device regulated environment.
• Strong understanding of medical device Design Controls and Risk Management principles.
• Experience preparing and reviewing quality and design documentation.
• Excellent analytical, communication, and organizational skills.
• Demonstrated ability to independently manage priorities and deliver results in cross-functional environments.

Why Join Us?

This role provides the opportunity to contribute to the development of innovative medical device technologies while working with multidisciplinary teams in a highly collaborative environment. You will play a critical role in ensuring that our products are safe, effective, compliant, and successfully transferred into manufacturing, ultimately improving the quality of life for people across the globe.