R&D India System Engineering Head

1 month ago

Hyderabad, India Allegis Global Solutions Full time

An exciting opportunity with a globally renowned leader in imaging technology in healthcare, pioneering innovative solutions that enhance people's lives every day


Experience

  • 14+ years of overall experience in systems engineering or medical device development with 10+ years in medical devices domain
  • 5+ years of experience with a medical devices company in a leadership role
  • 9+ years of experience in system development, system integration, and product design
  • Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.)
  • Proven track record of leading teams in the design and development of Class II/III medical systems

Skills

  • Strong technical background in systems engineering, system integration, and model-based engineering, with experience in Medical Device development and/or sustaining engineering efforts
  • Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning
  • Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps
  • Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth
  • Familiarity with Model-Based Systems Engineering (MBSE) and requirements management tools, ensuring cross-functional collaboration to achieve business objectives
  • Capable of developing deliverables to document system designs for high-volume manufacturing and quality compliance
  • Experience planning and mitigating system-level risks using tools like FMEA and fault tree analysis
  • Strong knowledge of system integration methodologies for medical devices and the ability to solve complex technical problems with sound judgment
  • Proficiency in working with requirements management systems, conducting risk analyses and DFMEAs
  • Excellent stakeholder management skills across PMO leads and vendor partners, ensuring timely project delivery and alignment with strategic goals
  • Experience managing large data sets, financial analysis, and P&L ownership, utilizing these insights to drive process improvements and operational efficiencies
  • Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership
  • Strong project management skills, with the ability to manage multiple projects simultaneously
  • Excellent communication, leadership, and problem-solving skills

Education

A degree or higher qualification in Systems Engineering, Biomedical Engineering, or related fields from a recognized university.

Master's in systems engineering will be an added advantage.

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