Medical Device Project Lead
bigtec Private LimitedBengaluru, Republic Of India, IN1 day ago
Job descriptionDrive alignment across hardware, software, assay, quality, regulatory, clinical, and manufacturing teams. Facilitate effective decision-making, issue resolution, and cross-departmental collaboration. 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. Identify and mitigate technical, operational, and compliance risks proactively. Monitor resource utilization and support strategic allocation to balance priorities across the portfolio. Ensure all projects follow ISO 13485 and relevant regulatory and QMS requirements. Drive robust documentation, design control processes, and phase-gate reviews. 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 preferred
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 Responsibilities
Program 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 :
Strategic Planning & Oversight :
Risk & Resource Management :
Governance & Compliance :
Qualifications & Experience
This is Full time 5 days a week onsite role at Rajajinagar, Bangalore.
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Project Lead • Bengaluru, Republic Of India, IN
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