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This individual will be part of and provide support to the Support to Sustaining Engineering team. In this role the individual will be part of the SPO team that leads the efforts in Change Management and related activities.
Job Responsibility:
Provide support to the Support to Sustaining Engineering team
Lead efforts in Change Management and related activities
Ensure successful initiation, planning and completion of small or complex project through monitoring, tracking and analyzing project activities and metrics
Serve as SPOC for team and collaborate with Project stakeholders
Ensure implementation of quality processes including Change control and design control activities
Preparation and review of project related documents, protocols and reports as required
Assist Project Manager in reviews and ensure project complies with QA processes and adhering to defined timelines
Review Changes to existing process and products and drive them via change control and ensure timely completion/closure
Work with Global team, Coordinate with different stakeholders (PDO, QA, RA, etc) to understand their requirements, prioritize the tasks and ensure the completion
Participate as well as Lead the meetings with cross functional team to communicate priorities, requirements, key issues/risks and ensure they are completely understood and set clear expectations
Independently drive the change controls
Resolve queries, concerns and drive the project to completion
Requirements:
Bachelor's or Master's degree in Bio Medical /Mechanical Engineering or Equivalent with 3+ years of experience in Sustaining Engineering projects
Excellent Verbal and Written skills in English
Excellent communication and presentation skill
Ability to communicate effectively in a multi-cultural working environment
Strong Collaboration and interpersonal skills
Ability to co-ordinate with stakeholders of cross functional and Leadership Team
Excellent critical thinking and problem-solving skills and application of methods and tools
Independent worker as well as Team Player with strong execution abilities to complete projects within timeline
Knowledge of US & EU Regulations and medical device standards – ISO 13485, ISO 14971