R&d india electrical engineering lead

4 days 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 medical or electrical engineering, maintenance, and management 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 medical device development, circuit boards, 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 devices Familiarity with product development lifecycle including concept, design, validation, and commercialization Skills Strong technical background in electrical engineering, electronics, and mechatronics, with experience in Medical Device development and/or sustaining engineering efforts Proficient in circuit design, PCB layout, power management, analog and digital signal processing, and microcontroller-based systems 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 Agile SCRUM environments and stage-gate processes, ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document product designs for high-volume manufacturing and quality compliance Technical expertise in printed circuit board design tools (Altium/Or CAD) and the ability to review schematics, component selection, and gerber data for PCB design and manufacturing Experience planning and mitigating electromagnetic compatibility challenges in electrical projects Strong knowledge of manufacturing methodologies for medical devices and the ability to solve complex technical problems with sound judgment Proficiency in working with requirements management systems like DOORS, JAMA, and conducting risk analyses and DFMEAs Excellent stakeholder management skills across PMO leads and vendor partner, 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 partner, 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 Biomedical / Electrical Engineering from a recognized university. Masters in biomedical /electrical engineering will be an added advantage.

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