Work multi-functionally with software development groups to ensure compliance to the functional safety standards and requirements; monitor and provide feedback of the functional safety status.
Guide and support engineers in applying software development methodology aligned with automotive safety standards; deep understanding of computer architecture and OS fundamentals.
Lead and develop a team of three medical research associates and a clinical science program manager. Provide medical monitoring to ensure patient safety and adequate coding and reporting of adverse events.
Participate in communication methods, such as safety meetings and notices to ensure relevant EHS information is communicated across the site by GC's and that management is included.
Promote safety culture and guide roll out of ISO 26262 processes, including training, tailoring, and tool adoption to facilitate implementation of compliant processes.
Contribute to the implementation and rollout of safety critical processes within the camera team to enable development of industry-leading safety critical software.
Monitors safety/regulatory related compliance to the Independent Contractor (IC) agreements, Independent Service Provider (ISP) agreements and other vendor contracts; develops the case for accountability measures and works with facility management to ensure corrective action.
Identify and assist in the management of safety concerns with the company's drug product(s). Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor. Responsible for writing documents required for assessment & communication of product safety information for core safety documents.
Support creation of Safety and Compliance goals for the site management and appropriate activity-based goals for the leadership team, managers, and supervisors to drive the safety culture, compliance and results.
Support the day-to-day running of applications to sustain Drug Safety objectives, including Argus Safety, MedDRA, Data Warehouse and Business Reporting tools .
Conducts trades and analyses and subsequently defines and recommends requirements to mitigate degrading conditions that affect safety, health, the environment or quality of work performance.
Develop, optimize, and verify tools within a tool chain that enables the full software product life cycle, starting from software requirements to software architecture, development, unit testing, integration testing, and validation.
Architect, develop, optimize, and verify a toolchain for the full software product life cycle, starting from software requirements to software architecture, development, unit testing, integration testing, and validation.
Leads projects related to physical security systems commissioning and roll-out. Coordinates with internal and external teams to manage scope, schedule, and deliverables.
Experience with analysis and implementation of system software requirements, executing static code analysis, and performing unit & integration testing on a number of projects.
Manage multiple interdependent projects of moderate to high complexity and scope. Use technical judgment to drive project delivery, challenge proposals and identify risks.