EMBEDDED SOFTWARE TEST ENGINEER @ EKCEL SYSTEMS
Ekcel Systems is seeking an experienced Embedded Software Test Engineer to join our team in Burlington, MA. This is a long-term, onsite position requiring five days a week at our facility. The ideal candidate will have over five years of experience specifically within the medical device industry, focusing on software verification and validation. You will be responsible for developing and executing comprehensive verification plans for both embedded and mobile systems in MedTech applications, ensuring all products meet the highest standards of safety and reliability. The role involves creating and maintaining detailed test protocols that comply with stringent industry standards such as FDA regulations, IEC 62304, and ISO 13485. You will work closely with the development team to ensure that all verification processes align with medical device regulations. Proficiency in embedded product verification and a deep understanding of regulatory requirements are essential for success in this role. This is a great opportunity for a professional looking to contribute to life-saving technology in a stable, long-term environment while working on cutting-edge medical software systems.
Key Requirements
5+ years of experience in SW verification and validation of Medical devices industry.
Develop and execute comprehensive verification plans for embedded and mobile systems in MedTech applications.
Create and maintain test protocols in compliance with FDA, IEC 62304, ISO 13485, and other relevant standards.
Ensure verification processes align with medical device regulations.
Proficient in verification of embedded products.
Proficient with medical device standards and regulatory requirements.
Availability to work onsite 5 days a week in Burlington, MA.
Strong understanding of the software development life cycle in regulated environments.
Experience with automated testing tools for embedded systems.
Excellent technical writing and documentation skills for compliance reporting.