Sr Eng, Advanced Surgery

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

This individual is part of Sustaining R&D Operations and provide support to PDO (Product Design/Development Owner) and PRMO (Product Risk Management Owner) and their team. In this role the individual is 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 is able to lead small-medium project.

Essential Duties & Responsibilities

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform
other duties as assigned.

• 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.

• Experienced in Design Verification and Validation and writing Test protocols/reports.

• Develop design control requirements and Involve in the Design reviews with cross functional team.

• Assist the PDO for maintaining the Design History file and related documents.

• Assist the PRMO for maintaining the Risk Management 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 supervision.

Qualifications

• 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 risks. Knowledge of applicable FDA, EU regulations and ISO standards including ISO13485, ISO 14971.

Education and/or Experience:
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.

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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