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 –Sr. Principal Engineer, Containers

Location – Whitefield, Bangalore

Shift – General

Job Responsibilities

As a Product Design Owner, considered as the global representative of the given product line.
Organize, plan, and execute activities related to product design changes and new product registration in compliance with current International/Regional/National regulations
Provide technical assessment and strategy for product changes related to Design, Labeling, Raw material, Supplier changes, Manufacturing process, Regulatory compliance, Quality improvements and New registrations.
Coordinate and ensure follow-up of technical activities in collaboration with global key stakeholders and manufacturing plants with respect to project commitment, quality procedures and business needs.
Collaborate with cross-functional teams, including product development group, sterility, marketing and quality assurance, to define and develop the solution bag requirements.
Thorough understanding of the Bio-design process and using the relevant tools to drive the exploration and new platform programs for Vantive Drug products organization
Provide technical guidance and mentorship to team members on best practices and technologies
Design and develop the solution bag, including the bag itself, the filling and sealing processes, and the packaging materials (secondary and tertiary)
Lead the program, testing and validation activities of the solution bag to ensure that it meets our user's needs and expectations
Develop the prototypes for optimizing the designs – prototypes prior to the full validation of the new designs
Work with our manufacturing partners to ensure that the solution bag can be efficiently and effectively produced on a large scale
Collaborate with our quality assurance team to ensure that the solution bag meets all relevant regulatory requirements and industry standards
Document and communicate the solution bag design, testing, and production processes to stakeholders
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
Responsible for the container process lab development to bridge the gap created due to separation and bloom
Driving the culture of innovations and Patentability of new ideas/concepts
Manages and conducts container technical reviews
Defines protocols and lead the necessary testing required to validate the safety and effectiveness of the design(s). Develop test plans, test protocols, and test reports for product integration testing
Develops, modifies, and approves the documentation, specifications and drawings
Develop the BOM for developed bag assemblies and ensure the technology transfer for the developed concept
Maintain the DHF documentation during the different stages of development till the product commercialization
Establish, maintain and update technical & Design documentation according to Good Documentation Practices
Hiring and mentoring Graduate Engineers and Research associates for various Engineering and Scientist roles within the organization.

Qualifications

Postgraduate in Polymer Science and technology or Mechanical engineer domain with 11 to 16 years of experience in polymer material development and design, including technical leadership. Prior experience in the Renal container's domain is a plus.
Exposure to flexible packaging film development and characterization.
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.

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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Sr Principal Engineer, Containers