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Senior Engineer, Acute Disposables

Senior Engineer, Acute Disposables

Vantive

3 - 6 years

7 - 10 Lacs

Bengaluru

Posted:18 hours ago| Platform:

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Skills Required

Fabrication Change management Medical devices ISO 13485 Prototype Critical care MS Office Risk management Troubleshooting Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

About Vantive

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 Summary
Job Title - Senior Engineer, Acute Disposables Location - Whitefield, Bangalore Shift - General

Job Description

You will be responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. The successful candidate will possess solid hands-on technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.

Project tasks involve development and maintenance of risk management files. Active support in Engineering change management with focus on risk, root cause analysis, solutions for CAPAs, NCRs, design implementation, verification & validation, standards compliance activities to ensure maintenance of state of the Art also from risk management perspective. Projects also include the development of new functions and features to be integrated into the existing products/new products.

Essential Duties and Responsibilities:

Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families.
Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones.
Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities.
Manages and prioritizes multiple projects and tasks.
Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques.
Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management.
Organizes and presents solutions from risk management perspective without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
Ensures successful integration of disposables design elements from risk management perspective into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the risk management tasks.
Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family.
Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing ensuring acceptable risk profile of the device is maintained throughout the entire product lifecycle.
Support, from risk management perspective, the necessary testing required to validate the safety and effectiveness of the design(s).

Education & Experience

Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent
Minimum of 6 years of relevant experience, Prior experience of technical leadership in Sustenance/New product development in Critical care Medical device domain is a plus.
Experience in a regulated industry preferably medical devices and familiarity with ISO 13485, and ISO 14971

Qualifications

Proficiency with MS Office and other office productivity tools.
Self-directed, resourceful, and able to work on multiple projects and priorities.
Strong organization, attention to detail, and documentation skills.
Strong hands-on lab skills, and prototype fabrication skills.
Very adept at grasping and solving complex problems using root-cause analysis techniques.
Previous experience on product risk management is a plus.
Ability to objectively identify technical solutions, and make sound engineering decisions.
Clear and effective communication (written and oral) and presentation skills.
A proven track record of effectiveness in a fast-paced environment.
Proven ability to create results within budget, timeline, and product/project deliverables.

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.

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Senior Engineer, Acute Disposables