EMBEDDED SOFTWARE TEST ENGINEER (MEDICAL DEVICE) @ EKCEL SYSTEMS
Ekcel Systems is seeking a highly skilled Embedded Software Test Engineer with specialized experience in the Medical Device industry for a long-term role. The successful candidate will be responsible for the verification and validation of software in embedded and mobile systems, ensuring that all MedTech applications meet the highest safety and performance standards. This is a critical position requiring five days a week onsite presence in Burlington, MA, to collaborate closely with the development and regulatory teams.
Key responsibilities include creating and maintaining comprehensive test protocols that strictly comply with FDA, IEC 62304, and ISO 13485 regulations. You will develop detailed verification plans and ensure that all engineering processes align with international medical device standards. This role demands a deep understanding of software quality assurance within a regulated environment and the ability to verify complex embedded products to support clinical safety.
Key responsibilities include creating and maintaining comprehensive test protocols that strictly comply with FDA, IEC 62304, and ISO 13485 regulations. You will develop detailed verification plans and ensure that all engineering processes align with international medical device standards. This role demands a deep understanding of software quality assurance within a regulated environment and the ability to verify complex embedded products to support clinical safety.
Key Requirements
Minimum of 5 years of experience in SW verification and validation within the Medical devices industry.
Must have extensive experience working specifically with Medical Device products.
Ability to develop and execute comprehensive verification plans for embedded and mobile systems.
Expertise in creating and maintaining test protocols in compliance with FDA standards.
Profound knowledge of IEC 62304 and ISO 13485 regulatory standards.
Proficiency in verification processes for embedded products in MedTech applications.
Strong understanding of international medical device regulations and safety requirements.
Willingness and ability to work onsite 5 days a week in Burlington, MA.
Proven track record in software quality assurance for regulated software systems.
Excellent analytical skills to ensure verification processes align with technical specifications.