R&D India System Engineering Head

4 weeks 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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