Principal Eng, Containers

Support and lead deliverables focused on technical execution and patient safety

Essential Duties And Responsibilities

• Execute end-to-end medical product development cycle activities according to the QMS, including requirement analysis, design specifications, sub-system integration, verification, release, transfer, production issue resolution, and related work.
• Collaborate with cross-functional teams across engineering poles and with system, hardware, QA, sourcing, manufacturing, service, and marketing teams.
• Develop, update, and approve electrical documentation, specifications, and drawings.
• Create and communicate design and test plans, tasks, deliverables, and project status.
• Manage time and resources to achieve committed schedule milestones.
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Qualifications

• Embedded Hardware, Firmware/RTOS, requirement writing (functional), System Architecture, System Lead, and contribution to system roadmap (portfolio) planning.
• Strong design fundamentals aligned with CFR21, IEC, ISO13485, ISO14971, MDD/MDR, and applicable country regulations for medical equipment.
• Working knowledge of RMF and DFMEA.
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Education And Experience

• A graduate or post graduate in Electrical or Electronics or related engineering, or equivalent engineering experience, with 12+ years of experience.
• Proven experience in electromechanical hardware design and development, preferably for medical devices or other highly regulated products.
• Specific experience in the design and development of sensing subsystems (flow and pressure sensors) is highly desirable.