Head of POC Systems Engineering & Instrument Integration

MHMI

Ottawa

On-site

CAD 172,000 - 241,000

Full time

14 days+

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Job summary

Siemens Healthineers in Ontario seeks a visionary leader to head the Systems Development and Integration (SDI) team within the Handheld Systems R&D organization, bridging hardware and software for point-of-care IVD instruments.

You will lead a multidisciplinary engineering group, drive quality and compliance with FDA, ISO, and IVDR standards, and shape product strategy with senior management. Willingness to travel is expected.

Qualifications

15+ years of R&D product development leadership in medical devices/IVD.
Hands-on Systems Engineering leader with full system architecture ownership.
Strong knowledge of FDA regulations, ISO 13485/14971, IVDR.
Experience integrating complex electromechanical systems across hardware and software.
Ability to operate in regulated environments and drive strategic execution.

Responsibilities

Mentor and develop a high-performing team across hardware, software, and systems.
Drive culture of trust, accountability, and continuous improvement.
Contribute to R&D Handheld leadership and broader POC business strategy.
Oversee development, integration, and delivery of electromechanical IVD instruments and software.
Partner with assay and consumable teams for hardware-to-consumable integration.
Collaborate with manufacturing for design transfer and scalable production.
Drive best practices in requirements, architecture, and risk management.
Ensure compliance with FDA, ISO, and IVDR quality standards.
Define and monitor KPIs for engineering output and product reliability.
Coordinate across functions to resolve impediments and ensure timely delivery.