Medical Device Systems Engineering Director
1 week ago
We are seeking an accomplished Medical Device Systems Engineering Director to lead our R&D engineering projects, ensuring seamless execution and strategic alignment with our business objectives.
Job OverviewThis exciting opportunity is part of Allegis Global Solutions' journey in pioneering innovative solutions that enhance people's lives every day. As a Medical Device Systems Engineering Director, you will be responsible for managing large-scale engineering projects, leading cross-functional teams, and driving technical excellence.
Responsibilities- Lead R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning
- Develop deliverables to document system designs for high-volume manufacturing and quality compliance
- Plan and mitigate system-level risks using tools like FMEA and fault tree analysis
- Work with requirements management systems, conducting risk analyses and DFMEAs
- Manage multiple projects simultaneously, prioritizing tasks and resources effectively
- 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 ability to work through medical device product lifecycle management, including FDA Design Controls and international standards
- Master's in systems engineering will be an added advantage
- 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
- Excellent stakeholder management skills across PMO leads and vendor partners
- A competitive salary range: $150,000 - $200,000 per annum
- Ongoing training and professional development opportunities
- A dynamic and collaborative work environment
- The chance to work on cutting-edge medical device projects
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