Job Description

Responsibilities:

• Lead project management activities as below.
• Lead and manage product activities in whole new product development milestones from development through to launch for assigned programs.
• Create Integrated Project Plan using various project management tools.
• Manage project plans, cross-functional team plans, master schedule and critical path.
• Be responsible for adherence to timelines and business requirements.
• Manage product cost and resource allocation across the project and manage resource allocation as needed.
• Manage project risks and develop contingency plans when needed.
• Capture project specific metrics and present them to Org Leadership Team, Project Sponsors and PMO.
• Create, maintain and update Project Plan to achieve required timelines. Communicate to key stakeholders if anything goes off track.
• Work with various functional groups involved including product development as needed i.e. (non-major projects - R&D, Supply Chain, Procurement, Regulatory Affairs etc).
• Ensure the following controls are in place for your project as per company procedure:
• Formal gate reviews.
• Manage timely completion of Design Verification and Validation activities.
• Create metrics for each design activity.
• Maintain project risk file and design history file.
• Maintain records of design inputs and changes.
• Ensure appropriate reviews are conducted for DS VV and Production.

Requirements:

• Bachelor's degree in mechanical engineering OR Bachelor's degree in Bio-Medical Engineering, OR Bachelor of Science with alternative specialization may be acceptable.
• At least 8 years' relevant experience in Project Management in Medical Devices.
• Experience in the execution of Project Management tools and processes.
• Must be experienced in planning, developing, managing and tracking activities at different levels of organization.
• Experience in people oriented, and cross-functional team and resource allocation.
• Must have the experience of handling cross-functional teams including cross-functional teams such as R&D, Regulatory, Clinical, Quality, Procurement, Manufacturing, Marketing etc.
• Must have experience in defining product development tasks and project deliverables.
• Must be able to prepare and present Program/Project Management Reports such as Gantt Chart, Swimlane Report, Milestone Report, Risk Register, Stakeholder Matrix and Program Status Reports.
• Must be able to proactively identify and manage project risks.
• Must be able to work in team and perform independently.
• Experience in Robotics, Digital Products and SaMD (Software as a Medical Device) and Sim'd (Software in a Medical Devices) would be preferable.
• Should be able to understand design history file, risk management file.
• Experience in Product Development phases and stages in Medical Devices industry.
• Should know the tools and techniques to manage multiple projects in parallel using MS Project or MS Project Full Monte or Planisware risk analysis software.
• Should have good management skills to manage complex cross-functional and cross-cultural teams are a must.
• Highly developed negotiation and influencing skills.
• Highly developed presentation and communication skills.
• Knowledge in Project Management and Program Management concepts and tools.
• Strong organizational planning skills.
• Conflict resolution skills.
• Willing to work and skilled in leading a variety of problem-solving methodologies.
• Metrics and workflow driven.
• Willing to undertake job responsibilities in remote locations.
• This profile will require the candidate identified to work as Project Manager in a New Product Development project with a MedTech client.
• The candidate must have Project Management experience. The candidate should also be experienced in medical device (preferably digital) product development.

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