About this role
Job Requirements Lead cross-functional teams in the development, commercialization, and life cycle management of Medical Devices, ensuring delivery within approved scope, budget, timeline, and quality objectives while maintaining compliance with global regulatory and quality requirements. Key Responsibilities · Plan, lead, and execute New Product Development (NPD), Sustaining Engineering, and Life Cycle Management (LCM) projects from concept through commercialization and post-market support. · Develop and maintain comprehensive project plans, schedules, budgets, resource plans, and governance structures to ensure successful program execution. · Drive product development activities across systems engineering, hardware, software, mechanical, electronics, verification & validation, manufacturing, quality, regulatory, and marketing functions. · Manage design and development activities in accordance with FDA Design Controls, ISO 13485, IEC 60601, ISO 14971, usability engineering, cybersecurity, and other applicable medical device standards. · Lead change management initiatives including product enhancements, cost reduction programs, obsolescence management, supplier changes, manufacturing transfers, and regulatory-driven updates. · Establish robust operating mechanisms and project governance frameworks to track milestones, monitor deliverables, manage dependencies, and drive accountability across global teams. · Identify project risks, perform risk assessments, develop mitigation strategies, and proactively drive issue resolution to ensure project objectives are achieved. · Collaborate closely with Quality Assurance, Regulatory Affairs, Clinical Affairs, Manufacturing, Supply Chain, Procurement, and external partners to ensure full product compliance and successful market release. · Manage design reviews, stage-gate reviews, technical reviews, and executive-level project reporting throughout the product development lifecycle. · Ensure effective stakeholder communication by providing regular updates on project health, risks, budget status, resource utilization, and key performance indicators (KPIs). · Drive continuous improvement initiatives by implementing best practices, lessons learned, project management methodologies, and operational excellence frameworks. · Support product sustaining activities including complaint investigations, CAPA execution, field actions, design changes, regulatory submissions, and post-market surveillance activities. · Mentor and coach project team members, fostering collaboration, accountability, technical excellence, and high-performance team culture. · Partner with senior leadership to align project priorities with business strategy, portfolio objectives, and customer requirements. --- You're the Right Fit If · B.E./B.Tech in Electronics, Mechanical, Biomedical Engineering, Mechatronics, or related discipline with 8+ years of experience, including at least 3+ years in project/program management within the medical device industry. · Proven experience leading end-to-end medical device product development programs, including design, verification & validation, regulatory submissions, product launch, and post-market lifecycle management. · Strong understanding of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, MDR, and global regulatory requirements. · Experience managing cross-functional global teams comprising R&D, Systems Engineering, Software, Electronics, Mechanical Engineering, Quality, Regulatory, Manufacturing, and Supply Chain functions. · Demonstrated success in leading sustaining engineering, product enhancement, cost reduction, supplier transition, and product obsolescence management programs. · Strong project management expertise with hands-on experience in project planning, budgeting, risk management, resource management, stakeholder management, and executive reporting. · Excellent communication, leadership, negotiation, and influencing skills with the ability to engage stakeholders at all organizational levels. · Technical background in complex medical devices, electronics, mechatronics, imaging systems, patient monitoring, therapy systems, or connected healthcare products. · Experience with Agile, Waterfall, or Hybrid development methodologies in regulated environments. · PMP/CAPM certification is highly desirable.