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/OrCAD) 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.
