Head of Systems Development & Integration — POC IVD

Siemens Healthineers

Ottawa

On-site

CAD 124,000 - 174,000

Full time

8 days ago

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Job summary

Siemens Healthineers seeks a visionary leader to head the Systems Development and Integration (SDI) team within the Handheld Systems R&D organization. You will bridge hardware and software across POC IVD instruments, guiding a multidisciplinary team to ensure quality, compliance, and timely delivery.

The role requires deep systems engineering expertise, 15+ years of R&D leadership in medical devices, and strong experience with FDA, ISO 13485/14971, IVDR.

Qualifications

  • Bachelor’s degree or higher in Systems Engineering, Master’s or Ph.D. preferred.
  • Minimum 15 years of R&D product development leadership in medical devices/IVD.
  • Hands-on Systems Engineering leader with full system architecture ownership.
  • Strong FDA/ISO/IVDR knowledge and compliance experience.

Responsibilities

  • Lead a multidisciplinary team across hardware, software, and systems engineering.
  • Drive development, integration, and delivery of electromechanical IVD instruments.
  • Collaborate with manufacturing and contract manufacturers for scalable production.
  • Define requirements, architecture, and risk management across product lifecycle.
  • Monitor KPIs to improve engineering output, predictability, and reliability.

Skills

Leadership
Systems engineering
Compliance
Regulatory knowledge

Education

Bachelor’s or higher in Systems Engineering
Master’s or Ph.D. preferred

Tools

Hardware-software integration

Job description

Siemens Healthineers seeks a visionary leader to head the Systems Development and Integration (SDI) team within the Handheld Systems R&D organization. You will bridge hardware and software across POC IVD instruments, guiding a multidisciplinary team to ensure quality, compliance, and timely delivery.

The role requires deep systems engineering expertise, 15+ years of R&D leadership in medical devices, and strong experience with FDA, ISO 13485/14971, IVDR.

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