Eng II, Advanced Surgery

Zvh; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Baxter is seeking a Sustaining Engineering professional to support the SPO team in Change Management and related activities. You will collaborate with cross-functional stakeholders to implement changes while ensuring QA and regulatory compliance.

The role focuses on initiating and driving project activities, coordinating with global teams, and leading change controls to timely completion, with emphasis on quality processes and effective communication across cultures.

Qualifications

• Bachelor’s or Master’s in Biomedical or Mechanical Engineering with 3+ years in Sustaining Engineering.
• Excellent verbal and written English skills.
• Strong communication and presentation abilities.
• Able to communicate effectively in a multi-cultural environment.
• Strong collaboration and interpersonal skills.
• Coordinate with cross-functional leadership and stakeholders.
• Excellent critical thinking and problem-solving using QA methods.
• Independent worker and team player with strong execution to meet timelines.
• Knowledge of US & EU regulations and medical device standards ISO 13485, ISO 14971.
• Experience with Change Management processes and tools.

Responsibilities

• Initiate, plan and monitor small to complex projects.
• Serve as SPOC for team and coordinate with stakeholders.
• Handle Change controls/Change Management activities.
• Ensure QA processes and design controls are followed.
• Prepare and review project documents, protocols and reports.
• Assist Project Manager in reviews and ensure timelines and QA compliance.
• Review changes to processes and drive them via change control.
• Coordinate with global teams and prioritize tasks across stakeholders.
• Lead cross-functional meetings to communicate priorities and expectations.
• Independently drive the change controls to completion.

Skills

Project initiation

SPOC role

Change management

QA processes

Documentation review

PM support

Change control

Cross-functional coord

Meeting leadership

Independent worker

Regulatory knowledge

Stakeholder coordination

Critical thinking

Education

Bachelor’s or Master’s in Biomedical/Mechanical Engineering

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Job Description

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.

Skills Required

• To 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.
• Handling of Change controls/Change Management activities.
• 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, Co-ordinate with different stakeholders (PDO, QA, RA, etc) to understand their requirements, prioritize the tasks & 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 (as needed) & drive the project to completion.

Qualifications

• 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.
• Should be able 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
• Good to have experience in Change Management process and Tools.

Equal 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

Baxteris committed to working with and providing reasonable accommodations to individuals with disabilities globally.

No matter your role at Baxter, your talent, skills, and timehas a direct impact on people's lives. Since 1931, wehave been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we’re more determined than ever to make a lasting impact as weare redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.