Principal Engineer, Containers

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.

Job Description

Job Title –Principal Engineer

Location – Whitefield, Bangalore

Shift – General

 Job Responsibilities:

·       As a PDO Support, lead the multi-functional technical team to facilitate effective collaboration and ensure timely delivery of project deliverables.

·       Organize, plan, and execute sustaining activities in compliance with current QA/ environmental/ regulations and standards  

·       Provide technical leadership, mentor, and guide the change owners and Project Leads within its product family to get tasks accomplished according to plans, milestones and business needs. 

·       Thorough understanding of the Bio-design process and using the relevant tools to drive the exploratory and new platform programs for Vantive Drug products organization

·       Collaborate with cross-functional teams, including product development group, sterility, marketing and quality assurance, to define and develop the solution bag requirements.

·       Lead the program, testing and validation activities of the solution bag to ensure that it meets our user’s needs and expectations

·       Identify and prioritize opportunities for improvement in the solution bag design, production, and testing processes. Ensures successful integration of material design and primary bag requirements

·       Leads the troubleshooting and problem-solving efforts related to aspects of the design and interfaces with the other devices (cyclers, solution generation devices etc.)

·       Responsible for development and documentation of container development activities – QTPP and other quality deliverables

·       Provides leadership to effectively transition products to manufacturing and ensure robust products and manufacturing processes

·       Driving the culture of innovations and Patentability of new ideas/concepts

·       Manages and conducts container technical reviews

·       Support to maintain the DHF documentation during the different stages of development till the product commercialization

·       Support for compilation of data and studies for PDO impact assessment

·       Lead DHF Gap remediation

·       Support data gathering, compilation and analysis for market complaints, and regulatory changes.

·       Support PDO/PRMO for data analysis and drafting the reports.

·       Support for data gathering for the risk reviews, own PRR change controls.

·       Draft Protocols and reports for Technology Transfer, V&V studies, Import license, test license and other logistics.

Qualifications

·       Postgraduate in Polymer Science and technology or Mechanical engineer domain with 8 to 11 years of experience in polymer material development and design, including technical leadership. Prior experience in the Renal container’s domain is a plus.

·       A demonstrated track record and experience in polymeric material development, preferably in primary packaging for healthcare

·       A proven track record of management/leadership effectiveness in a fast-paced environment

·       Proven ability to create results within budget, timeline, and product/project deliverables

·       Clear and effective communication (written, oral) and presentation skills

·       Good stakeholder management (local and global)

·       A proven track record of effectiveness in a fast-paced environment

·       Proven ability to create results within budget, timeline, and product/project deliverables

Skills

·       Excellent English verbal and written communication skills.

·       Self-directed, resourceful, and able to work on multiple projects and priorities.

·       Strong organization, attention to detail, and documentation skills.

·       Very adept at grasping and solving complex problems using root-cause analysis techniques.

• Ability to objectively identify technical solutions and make sound decisions.

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

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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