Sr. Engineer

Vantive; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Vantive is seeking a Tech Lead to support the Extraneal Risk Management (ERM) program by updating and maintaining webpages and related quality documents across SPO, HD and NPD programs. This role acts as the single point of contact for ERM-related documentation and coordinates with global stakeholders to ensure timely, compliant updates.

The ideal candidate has a technical engineering background with 5+ years of experience, strong regulatory knowledge, and proven ability to lead multiple

Qualifications

• Knowledge of product development stages, life cycle management and design control.
• Working knowledge of international/regional/national regulations and standards.
• Ability to work independently.
• Ability to manage simultaneously several projects and shift priority according to needs.
• Ability to solve problems, develop solutions, and make recommendations in collaboration with senior technical leaders.
• Ability to deliver results according to the plan.
• Good communication skills.

Responsibilities

• Lead webpage updates and support for Extraneal Risk Management program.
• Define, organize, plan and execute ERM webpage updates with stakeholders.
• Ensure timely ERM updates in compliance with local regulations.
• Single point of contact for uploading and issuing quality documents across SPO and NPD programs.
• Coordinate technical activities with stakeholders, maintaining quality procedures and business needs.
• Establish, maintain and update technical & Design documentation according to Good Documentation Practices.
• Participate in multi-functional and international project teams.
• Ensure regular status updates of activities.

Skills

Knowledge of product development

Regulatory knowledge

Independent work

Multi-project coordination

Problem solving

Deliver results

Communication skills

Education

Bachelor's Degree in engineering

5+ years of relevant experience

Experience in coordination of technical projects

Excellent verbal and written communication skills

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

• Responsible to support the global Extraneal Risk Management Program (ERM) around website updates and related webpage support in compliance to the local regulations and quality requirements
• Thorough understanding of the documentation and Extraneal Risk Management program
• Act as the single point of contact for uploading all the quality documents across all the three modalities – PD< HD and Acute (SPO and NPD)

Essential Duties and Responsibilities:

• As Tech Lead, considered to be key focal point for webpage related updates and support for Extraneal Risk Management program.
• Define, organize, plan and execute activities related to ERM webpage updates, code creation, branding updates as needed in consultation with the global stakeholders
• Timely completion of the updates related to ERM program in compliance with the local regulations
• Single point of contact for the Drug products organization for the uploading and issuance of quality documents across all the modalities for both SPO and NPD programs
• Coordinate and ensure follow-up of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs
• Propose options and develop action plan for problem-solving, product and process improvement in the area of interestEstablish, maintain and update technical & Design documentation according to Good Documentation Practices
• Participate to multi-functional and international project team
• Ensure good internal and cross-functional communication and regular status update of activities
• Quick learner and ability to perform the role with minimal guidance
• Responsible for product compliance and execution as part of the ERM program

Qualifications:

• Bachelors in any field of engineering with a minimum of 5 years of relevant work experience
• Knowledge of product development stages, life cycle management and design control with time
• Working knowledge of international/regional/national regulations and standards
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Ability to solve problems, develop solutions, and make recommendations in collaboration with senior technical leaders
• Ability to deliver results according to the plan
• Good communication skills

Education and/or Experience:

• Bachelor's Degree in a technical discipline preferably engineering
• Min 5+ years of relevant experience
• Experience in coordination of technical projects
• Excellent verbal and written communication skills

Reasonable Accommodation

Vantive 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. Form Link

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