Senior Engineering Leader Medical Devices

Job Title: Senior Engineering Leader Medical Devices

Location: Pune, India

Experience: 15+ years

About the Role

We are looking for an experienced and visionary professional with a strong engineering background and proven expertise in the medical devices industry. The ideal candidate will bring 15+ years of domain experience across product development, system engineering, solutions design, and delivery of innovative medical device technologies. This role requires strong leadership, technical depth, and the ability to drive end-to-end engineering programs in alignment with regulatory and compliance standards.

Key Responsibilities

• Lead engineering programs across medical devices domain with focus on solutions, innovation, and compliance.
• Drive end-to-end product development lifecycle from concept, requirements, design, validation, and certification to launch.
• Provide technical leadership in areas such as embedded software, hardware, cloud/IoT integration, connectivity, and digital health solutions.
• Ensure adherence to regulatory requirements (ISO 13485, IEC 60601, FDA, MDR) and industry best practices.
• Partner with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to deliver robust solutions.
• Build and mentor high-performing engineering teams with focus on domain expertise and upskilling.
• Collaborate with global stakeholders and customers to define solution roadmaps aligned with business objectives.
• Drive continuous improvement, innovation, and cost optimization across engineering programs.

Required Skills & Experience

• Bachelors/Master’s degree in Engineering (Electronics, Biomedical, Computer Science, or related field).
• 15+ years of experience in Medical Devices industry with deep domain expertise.
• Proven track record in solutions engineering, product development, and systems integration.
• Strong understanding of embedded systems, cloud/IoT, AI/ML in healthcare, connectivity, and cybersecurity.
• Hands-on experience with medical device standards, certifications, and regulatory compliance.
• Demonstrated ability to lead engineering teams and manage large-scale, complex projects.
• Excellent communication, stakeholder management, and leadership skills.

Preferred Qualifications

• Experience in digital health solutions, connected devices, and medical software platforms.
• Knowledge of risk management (ISO 14971), usability engineering (IEC 62366), and quality systems.
• Global exposure working with US/EU customers and regulatory agencies.