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Premium Employer

Vantive

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5.0

based on 1 Review

24 Vantive Jobs

R&D Project Leader II - LSI

Vantive

5.0

based on 1 Review

10-13 years

Bangalore / Bengaluru

1 vacancy

R&D Project Leader II - LSI

Vantive

posted 10d ago

Job Role Insights

Key skills for the job

Healthcare Legal Advisory Project Management Recruitment Risk Management Medical Devices

+ 2 more

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.