-Program Manager -Life Cycle Manager- Medical Devices
Job Description
In this role, you have the opportunity to prepare and implement single discipline project or sub-projects of an integral project, in accordance with agreed conditions on specification, time, cost and staffing. PQ&M Manager is responsible for execution, progress and quality of the project.
You are responsible for
• Life Cycle Manager for Mobile Surgery Installed Base of Product(s)/Product line(s).
• Manage the obsolescence and product issues
• Effectively resolve customer complaints or production issues
• Manage the internal and external stakeholders effectively
• Manage the multi-disciplinary cross functional team (R&D, Operations, Supply Chain, Service, Marketing, Procurement, Quality,Regulatory,) to realize results
• Prepare, plan, track and coordinate cross functional teams located across geographies and manage project deliverable.
• Accountable for overall delivery of project in line with QMS and PRP process as per the agreed multi-site Quality Agreement.
• Communicate and collaborate with the different stakeholders (e.g., supply chain, business, program management).
• Manage the business risks related to Production.
• Managing and Reporting of key KPIs to senior management
• Coaching and Supporting junior team members
• Ensuring business continuity and revenues.
• Experience with OEM/ODM suppliers is highly appreciated.
To succeed in this role, you should have the following skills and experience
• Master/Bachelor in Electronics Engineering with 10+years of experience in
• 10 Yrs+ of hands-on experience in leading medical devices / products development / maintenance/sustenance. ( at least 5 years in actual engineering design and development and transfer )
• 3+ years of Experience in LCM management / Project management is highly preferred. PMI/PMP Competencies like project management (i.e MS-Project plus Agile/Waterfall project planning & execution. Change management and lifecycle management experience.
• Experience with ERP systems such as SAP. Experience in PDLM tools like Windchill.
• Experience in configuration management, tools and techniques is highly preferred.
• Experience in X-Ray based products like Mobile Surgery, or other Diagnostic X-Ray based products is required.
• Knowledge on the QMS procedures of Medical devices, with ISO-13485, FDA and other Medical Regulatory requirements is expected.
• Experience in the end to end Design eco-system of Medical products is desired.
• Fast learner and interest to learn new technologies/business/systems.
• System thinking mindset
• Excellent communication skills
• Team player
• Leadership skills and drive for results
• Mindset to simplify and reach to solutions with speed.
• A flexible mind set, happy to pivot and work in a changing environment
• Power of persuasion, able to convey enthusiasm