Project Manager

2 weeks ago

Bengaluru, India bigtec Private Limited Full time

We are seeking an accomplished and strategic Project Manager – R&D to lead critical product development initiatives at Bigtec. This role is central to the execution of high-priority IVD medical device projects from concept through production, ensuring delivery on time, within budget, and in compliance with quality and regulatory standards.Key ResponsibilitiesProgram Leadership:- Lead end-to-end execution of Bigtec’s most critical R&D projects, including complex, multi-phase IVD product developments.- Serve as the central point of accountability for project planning, execution, risk management, and delivery.Cross-Functional Coordination:- Drive alignment across hardware, software, assay, quality, regulatory, clinical, and manufacturing teams.- Facilitate effective decision-making, issue resolution, and cross-departmental collaboration.Strategic Planning & Oversight:- Define project scope, milestones, and success criteria in collaboration with leadership and functional heads.- Develop and maintain detailed program roadmaps and dashboards for executive reporting.Risk & Resource Management:- Identify and mitigate technical, operational, and compliance risks proactively.- Monitor resource utilization and support strategic allocation to balance priorities across the portfolio.Governance & Compliance:- Ensure all projects follow ISO 13485 and relevant regulatory and QMS requirements.- Drive robust documentation, design control processes, and phase-gate reviews.Qualifications & Experience- Bachelor’s or Master’s degree in Engineering or Science discipline is required.- 5 to 10 years of experience with at least 3 years in medical device, biotechnology or IVD product development.- Demonstrated success in leading full lifecycle development of regulated medical products, preferably point-of-care or diagnostics devices.- Familiarity with design controls, ISO 13485, and risk management (ISO 14971). PMP or equivalent certification preferredThis is Full time 5 days a week onsite role at Rajajinagar, Bangalore.

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