Sr Solutions Engineer – Manufacturing
iRhythm TechnologiesFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Candidates must possess a Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related field, coupled with over 5 years of experience in systems engineering for regulated medical devices or software as a medical device (SaMD). A strong understanding of FDA, EU MDR, and ISO regulations, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485, is essential. Demonstrated expertise in requirements management, traceability, risk management, and usability engineering compliant with IEC 62366 is required, along with excellent technical writing skills for regulatory submissions. Familiarity with requirements management tools and strong cross-functional collaboration skills are also necessary.
The Systems Engineer will lead requirements engineering, ensuring a high-quality, traceable process and developing systems for requirements traceability. They will also spearhead software risk management activities, including hazard analysis, risk classification, and documentation, and manage risks during product changes and post-market surveillance. Responsibilities include creating and maintaining system architecture documentation, defining system diagrams, and planning and executing usability engineering activities such as formative and summative studies. Additionally, the role involves authoring and reviewing regulatory submission sections, supporting responses to regulatory questions, and contributing to the continuous improvement of the Quality Management System.
SaaS digital health messaging integration platform
Artera is a compelling workplace due to its critical role in improving healthcare communication, orchestrating over 2.2 billion messages annually across diverse channels like texting, email, and webchat. The company not only facilitates efficient healthcare staff operations and profitability for organizations but also enhances overall patient experience by supporting services in over 109 languages. This broad impact in healthcare through high-level integration with EHRs and third-party vendors positions Artera as a leader in the digital health sector.