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12 Vantive Jobs

R&D Project Leader II - LSI

10-13 years

Bangalore / Bengaluru

1 vacancy

R&D Project Leader II - LSI

Vantive

posted 18hr ago

Job Description

The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment. Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems.
 
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
  • Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products
  • Owner of R&D program schedule creation, tracking, and execution. Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans.
  • Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables
  • Accountable for project execution and proactive risk management. Effectively tracks project status, risks, budget, and external spend.
  • Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
  • Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis
  • Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project
  • Establish project communication channels and archives. eg, Teams group, Status meetings, Escalation matrix, etc
  • Facilitate/organize DPS R&D project design reviews and change control meetings
  • Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (eg, external labs, translation agencies, etc)
  • Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities
Qualifications . To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
  • Experience in project management principles and methodologies
  • Strong interpersonal and communication skills in written and verbal form
  • Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc).
  • Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope.
  • Ability to decompose complex problems into actionable plans and track them to closure
  • Understanding of design requirements for development, validation, and verification of medical products
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
  • Bachelors degree in Engineering, Science or related field
  • 10+ years of relevant R&D, Project management (or similar) experience preferred
  • Experience in pharmaceuticals or medical product industry preferred

Employment Type: Full Time, Permanent

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