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This individual will be part of and provide support to PDO (Product Design/Development Owner) and their team. In this role the individual will be part of the sustaining team that leads the efforts in providing all the necessary design and technical information related to the product, address queries raised by the Cross functional teams and stakeholders (such as RA, QA, Manufacturing, Marketing, etc.). Individual will be able to lead small-medium project.
Skills Required
To ensure successful initiation, planning and completion of small-medium or complex project through monitoring, tracking, and analyzing project activities and metrics.Serve as Single Point of Contact for team and collaborate with Project stakeholders.Demonstrated experience in Design and Development of medical devices, sustaining activities and related process.Knowledge of applicable FDA, EU regulations and ISO standards including ISO13485, ISO 14971.Demonstrated experience in preparing Design History File and Product Risk Management activities is desirable.Experienced in Design Verification and Validation and writing Test protocols/reports in desirable.Develop design control requirements and Involve in the Design reviews with cross functional team is desirable.Assist the PDO for maintaining the Design History file and related documents.Provide support to cross functional team by Understanding the needs, addressing technical queries/requirements and regulations.Provide Support as required to sustaining engineering projects.Experienced in handling Engineering/Design Change Management process.Extensive knowledge and hands on experience in Good Documentation Practice.Perform tasks with minimal supervisionQualifications:
Bachelor’s or Master’s degree in Mechanical Engineering/ Bio Medical Engineering or Equivalent with 4+ years of experience in Sustaining Engineering projects for Medical Devices.
Excellent Verbal and Written skills in English.Excellent communication and presentation skill. Should be able to communicate effectively in a multi-cultural working environment.Strong Collaboration and interpersonal skills.Ability to co-ordinate with stakeholders and Leadership Team.Excellent critical thinking and problem-solving skills and application of methods and tools.Willing to take ownership and take accountability for actions.Maintain timelines for successful completion of activities.Ability to identify and proactively mitigate risksEqual Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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