Senior Engineer, S/W QA

Responsible for providing Quality Engineering Input to support Manufacturing, Manufacturing Engineering, and R&D activities that involve the development or use of software products. Develops, applies, revises, and maintains quality standards for software products that the company develops as part of finished products or in support of manufacturing, manufacturing engineering, or quality processes. Actively participates in New Product Development, Design Review, and Design Control Activities, as related to software products. Develops and implements Process and Product Software Verification and Validation activities with reference to external standards and regulations, such as FDA, ISO, IEEE. Leads the activities associated with the Software products risk assessment. Provides technical guidance and training to other Department members in Software QA Engineering areas of expertise. Controls and maintains the database for tracking defects associated with the products during the design life cycle. Provides input to, defines and approves Product and Process Validations and Reports. Establishes requirements for Installation and Operational Qualifications for new and replacement equipment. Bachelors (or higher) degree in engineering with preference Computer Science. 9+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation. Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. Sound understanding of medical device regulatory requirements for Class II and III medical devices. Project planning - resourcing, timelines, quality and budgets. Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Preference for candidates with CQE certification or similar training and experience Proficient in project management tools like MS project. Experience in ISO 62304.