Senior Product Software Engineer - Program Manager

at  Capgemini

JOB DESCRIPTION:

Opportunity to work with one of the largest MedTech client for defining and complying with IT processes.

KEY SKILLS REQUIRED

• Bachelor’s degree in computer science, Engineering, or related field
• At least 10 years’ experience in either project management, business systems analysis, software development or deployment.
• 6+ years of experience delivery of complaint handling solutions/Operations/Applications
• IT and Manufacturing/Engineering Project/Program management experience in large or midsized. multinational Health Care, Medical Device, or Consumer Goods organization preferred.
• Experience with GxP validation.
• Experience navigating large organizations and an understanding of complex stakeholder relationships is a must.
• Strong leadership skills and a passion for translating findings into strategic recommendations
• Proven ability to design and optimize processes.
• Demonstrated ability to assess customer/client needs, creatively approach solutions, decide and influence appropriate courses of action.
• Mature communicator capable of ruthless prioritization, gracious compromise, and quick decision-making.
• Proven ability to design and optimize processes.
• Demonstrated ability to assess customer/client needs, creatively approach solutions, decide and influence appropriate courses of action.
• Mature communicator capable of ruthless prioritization, gracious compromise, and quick decision-making.

oSupport the medical device software lifecycle (SLC) including change request, software validation, requirements, documentation in compliance with client’s IT processes.

• Assess and analyze complex business challenges to provide insights to stakeholders.
• Define functional and technical requirements to support development of business solutions.
• Coordinate delivery efforts to meet project milestones and objectives.
• Facilitate resolution of operational issues ensuring acceptable system testing and timely deployments in collaboration with IT and external vendors to help operations conduct business more effectively.
• communicate effectively with all levels of the organization.
• Ensure adherence to relevant regulatory, corporate, and quality standards including Corrective Actions and Preventive Actions (CAPA)
• Maintain robust cybersecurity, privacy, and security protocols.
• Supporting multiple internal and external audits throughout the year
• Maintain system protocols by implementation policies and procedures in accordance with Quality Management System (QMS) policies.
• Initiates or maintains schedule for projects and program milestones.
• Provide project management consultation and mentorship of the various project phases and the deliverables such as: development and execution of the project schedules; baselines; analyzing critical paths; schedule management; resource planning; risk/issue identification and control; project change requests; weekly and monthly status reporting

• Manage projects from initiation to closure ensuring timely delivery including
  oManaging end to end SLC process

oSupport the medical device software lifecycle (SLC) including change request, software validation, requirements, documentation in compliance with client’s IT processes.

• Assess and analyze complex business challenges to provide insights to stakeholders.
• Define functional and technical requirements to support development of business solutions.
• Coordinate delivery efforts to meet project milestones and objectives.
• Facilitate resolution of operational issues ensuring acceptable system testing and timely deployments in collaboration with IT and external vendors to help operations conduct business more effectively.
• communicate effectively with all levels of the organization.
• Ensure adherence to relevant regulatory, corporate, and quality standards including Corrective Actions and Preventive Actions (CAPA)
• Maintain robust cybersecurity, privacy, and security protocols.
• Supporting multiple internal and external audits throughout the year
• Maintain system protocols by implementation policies and procedures in accordance with Quality Management System (QMS) policies.
• Initiates or maintains schedule for projects and program milestones.
• Provide project management consultation and mentorship of the various project phases and the deliverables such as: development and execution of the project schedules; baselines; analyzing critical paths; schedule management; resource planning; risk/issue identification and control; project change requests; weekly and monthly status reporting.