Description:

Sword Health is seeking a Quality Engineer (Software-focused) to ensure the quality and regulatory compliance of software-based medical devices.
The role involves collaborating with cross-functional teams, including software development, regulatory affairs, and quality assurance, to uphold safety and effectiveness standards.
Responsibilities include developing and implementing quality assurance processes specific to software development for medical devices, guiding product development teams through compliance procedures, conducting software risk analysis, and supporting software build and maintenance activities.
The position also involves staying updated on industry standards and regulations, collaborating on risk management, planning and executing software verification and validation activities, maintaining accurate documentation, and providing training and support to internal teams.
The ideal candidate should have a Bachelor's degree in Science, Engineering, or related discipline, 3+ years of experience in Quality Software Engineering within a regulated environment, familiarity with relevant quality standards and regulations, strong analytical and communication skills, and fluency in English.

Requirements:

Bachelor's degree in Science, Engineering, or related discipline.
3+ years of experience in Quality Software Engineering or a related role within a regulated environment, preferably in medical devices or pharmaceuticals.
Experience in medical device new product development preferred.
Relevant work experience in Software quality management of medical devices including Software as Medical Device (SaMD).
Strong knowledge of software development lifecycle processes and best practices (e.g Agile, Waterfall).
Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, SiMD IEC 62304, SaMD IEC 82304, FDA 21 CFR [820.30], FDA CFR part 11 Compliance, knowledge and experience with FDA General Principles of Software Validation, IEC 14971 Risk Management, IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness and Security, UL 2900-1 Cybersecurity Standard for Medical Devices.
Experience with risk management methodologies (e.g. FMEA).
Excellent analytical, problem-solving, and communication skills.
Experience with Agile, Jira, Confluence preferred.
Fluent in English.