R&D India System Engineering Head
4 weeks ago
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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