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Principal Engineer, Acute Disposables

10.00 to 12.00 Years   Bangalore   21 Oct, 2021
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Job Title Principal Engineer, Acute Disposables Location Whitefield, Bangalore Shift GeneralJob 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.Projects are focused on performance improvement of existing products, Project tasks involve Engineering change management, root cause analysis, solutions for CAPAs, NCRs, design implementation, verification & validation, Value improvement programs and standards compliance activities. 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. 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.
  • Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.
  • Manages and prioritizes multiple projects and tasks.
  • Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques and sound analysis-based engineering by applying principles of mechanics, thermodynamics, hydraulics, heat transfer and materials where required.
  • Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management.
  • Organizes and presents technical project management overviews without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
  • Ensures successful integration of disposables design elements into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the engineering and design 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. Ensures Systems that are optimized for production, reliability, regulatory compliance and cost.
  • Provides leadership to effectively transition products to manufacturing and ensure robust products and manufacturing processes.
  • Performs in-depth mechanical engineering analysis and calculations.
  • Manages integration of deliverables from sub-system design teams and external partners.
  • Defines protocols and conduct 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, also develops the infra required for the testing.
Education & Experience
  • Graduate or Postgraduate in Mechanical Engineering or Equivalent
  • Minimum of 10 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.
  • Hands on creating, developing and testing designs from prototypes through production implementation.
  • 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.
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Keyskills :
javalinuxjavascriptframeworkbill of materialsroot cause analysisengineering change managementcontinuous improvement facilitationstatements of work sow

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