Senior Engineering Project Manager – Ultrasound Hardware (Hybrid NYC)
职位介绍
Responsibilities:
- Own planning and execution of technical projects across R&D, product development, New Product Introduction, and regulatory compliance for ultrasound hardware.
- Lead cross-functional collaboration with engineering, regulatory, quality, legal, and supply chain to keep initiatives on track.
- Budgeting, forecasting, and internal time tracking to support accurate financial reporting.
- Maintain alignment between technical roadmaps and partner goals; ensure deliverables meet strategic objectives.
- Track milestones, dependencies, and risks; implement mitigation plans.
- Coordinate regulatory and quality activities to ensure medical device compliance with FDA QSR, ISO 13485, IEC 60601 and related standards.
- Oversee procurement, production scheduling, and logistics to ensure timely delivery of products and components.
- Identify bottlenecks and drive process improvements to increase efficiency and throughput.
Qualifications:
- Bachelor's or Master's degree in Engineering, Computer Science, or related field.
- 5+ years of program/project management experience managing complex technical hardware projects, preferably in hardware/semiconductors or deep tech.
- Strong data-driven approach to project tracking and reporting; proficient with analytics tools.
- Excellent communication and stakeholder management skills; able to translate technical challenges into actionable plans.
- Experience in regulated industries with familiarity with ISO 13485, FDA QSR, IEC 60601 or similar standards.
- Ability to work across hardware, software, and regulatory teams.
Preferred:
- PMP, PgMP, or equivalent certification.
- Experience with ultrasound or medical imaging.
- Exposure to high-volume manufacturing.
- Understanding of software development processes and integration workflows.
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