Senior Design Assurance Engineer I, Software

Responsibilities: Under general managerial supervision/oversight, works with development teams in the following areas: Work with application developers and product teams to support the development of medical devices with software. Support the development and qualification of software development tools and services Assist in the review of the software test cases and test runs in support of design verification/validation activities Review Software Design Documentation Support in risk management activities for effective product development and operational activities ensuring compliance with ISO 14971, IEC 62304, ANSI/AAMI SW96. Support changes to product designs. Assist in engineering change order preparation/review Assist in quality system procedures periodic review Assist QE CAPA owners on CAPA task follow up. Assess and improve quality system processes through data monitoring and trend analysis. May participate in internal audits, conducting audits. Other duties as assigned to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives. Experience 5+ years of medical device experience or experience in a semi-regulated industry is required; 8+ years preferred.

Knowledge, Skills and Abilities: Strong knowledge of medical device manufacturing and software development. In-depth knowledge of GMP, ISO 13485 (note: original text indicated ISO 13845), ISO 14971, EU MDD/MDR, GDPR, and 21 CFR Part 820 FDA requirements, ISO 62304 and IEC 60601 software requirements. Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques). Proficiency in programming languages such as C++, Java, or Python, and experience with software development tools (version control, bug tracking, automated testing). Excellent documentation skills, attention to detail and accuracy. Team player with good written and oral communication. Organized with the ability to coordinate activities with internal departments and outside vendors. Establishes reputation as an emerging leader with sustained performance. Demonstrates strategic thinking and commercial/industry understanding in functional projects. Proficient data entry and typing skills. ERP systems experience required. EducationBachelor’s degree required. In lieu of a Bachelor’s degree, an Associate's degree or upper education certification program in a science or engineering field is acceptable. Senioriority levelMid-Senior level Employment typeFull-time Job functionEngineering and Quality Assurance IndustriesBiotechnology Research Pharmaceutical Manufacturing Medical Equipment Manufacturing