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:
Bachelors degree in mechanical engineering OR Bachelors 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 Simd (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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