Medical Device Innovation Leader

1 day ago

Shimoga, Karnataka, India beBeeMedicalDevice Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Summary:

We are seeking a seasoned professional to lead and grow our medical segment in India. The ideal candidate will bring deep domain expertise in medical devices, a strong understanding of regulatory frameworks, and a proven track record in managing cross-functional teams across product development, compliance, and client engagement.

The successful candidate will be responsible for driving the vision, roadmap, and execution strategy for the medical segment in alignment with global business goals. This includes leading end-to-end development of medical devices or healthcare solutions, ensuring compliance with ISO 13485, IEC 62304, and FDA regulations.

Additionally, the candidate will act as the primary point of contact for key medical clients, understanding their needs and translating them into actionable engineering and business plans. They will also mentor and lead a multidisciplinary team of engineers, regulatory experts, and project managers.

Innovation & R&D:

Collaborate with internal R&D teams to drive innovation in areas such as wearable health tech, diagnostics, imaging, and connected care.

Regulatory & Quality Compliance:

Ensure all products and processes meet global regulatory standards and quality benchmarks.

  • Key Responsibilities:
  • Strategic Leadership:
  • Drive the vision, roadmap, and execution strategy for the medical segment in alignment with global business goals.
  • Project & Program Management:
  • Lead end-to-end development of medical devices or healthcare solutions, ensuring compliance with ISO 13485, IEC 62304, and FDA regulations.
  • Client Engagement:
  • Act as the primary point of contact for key medical clients, understanding their needs and translating them into actionable engineering and business plans.
  • Team Management:
  • Mentor and lead a multidisciplinary team of engineers, regulatory experts, and project managers.
  • Innovation & R&D:
  • Collaborate with internal R&D teams to drive innovation in areas such as wearable health tech, diagnostics, imaging, and connected care.
  • Regulatory & Quality Compliance:
  • Ensure all products and processes meet global regulatory standards and quality benchmarks.
  • Required Skills & Experience:
  • 10+ years of experience in the medical device or healthcare technology industry.
  • Strong knowledge of medical standards (ISO 13485, IEC 60601, IEC 62304, FDA 21 CFR Part 820).
  • Experience in embedded systems, software development, or systems engineering for medical applications.
  • Proven leadership in managing large teams and complex programs.
  • Excellent communication and stakeholder management skills.
  • Preferred Qualifications:
  • Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.
  • PMP or equivalent project management certification.
  • Exposure to AI/ML in healthcare or digital health platforms is a plus.

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