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Quality Assurance Lead III
Ref No.: 15-03719
Location: Cambridge, Massachusetts
Owns full responsibility for the DHF of a product with primary focus on design inputs, outputs and traceability.
Supports internal and external audits by presenting the DHF and providing required information to auditors.
Works with the internal and external software development teams to define the right granularity of software requirements and specifications as well as subsystem decomposition.
Creates documentation of system requirements, design specifications, installation instructions, and other system-related information.
Assures that all requirements have been implemented in the design.
Creates functional or system standards to ensure operational requirements, quality requirements, and design constraints are addressed.
Contributes to the development of system engineering, software engineering, system integration, or distributed system architectures and documentation as it relates to DHF.
Improves operations by conducting systems analysis; recommending changes in policies and procedures.
Updates job knowledge by studying state-of-the-art tools, techniques, and computing equipment; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Requirements
BS in Computer Science or equivalent
5+ years' experience in embedded systems, wireless communication, software and communication architecture design, communication protocols and encryption techniques
Experience in modern communication protocols including Bluetooth and Bluetooth Smart/Low Energy
Experience in medical device development

Desired Skills
MS in Computer Science or equivalent
Software programming with Javascript/Java/C#/C++
Knowledge of cloud based systems, communication systems and databases
Experience with 21 CFR Part 11
Strong analytical and problem-solving skills, ability to quickly understand complex technical systems
Good English communication (written and oral) and collaboration skills
Ability to collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results
Ability to understand, meet and exceed internal and external customer expectations to create positive impact
Ability to think and plan broadly and long term to inspire excellence in execution