Senior Director, Medical Device Systems & Integration

Siemens Healthineers; Ottawa; On-site; CAD 170,000 - 239,000; Full time

Benefits offered by this job

Flexible benefits plan

Defined Contribution Pension Plan

RRSP matching contributions

Generous PTO and holidays

Job summary

Siemens Healthineers is seeking a visionary leader to head the Systems Development and Integration team within the Handheld Systems R&D organization. You will bridge hardware and software in POC IVD instruments, guiding a multidisciplinary team and ensuring compliance with FDA, ISO, and IVDR regulations.

This executive role reports to the VP of R&D Handheld Systems and requires strong strategy, risk management, and delivery focus.

Qualifications

• Minimum 15 years of progressive R&D product development leadership in medical device/IVD space.
• Hands‑on systems engineering leader with full architecture ownership and risk mitigation.
• Strong knowledge of FDA, ISO 13485/14971 and IVDR compliance.

Responsibilities

• Lead a multidisciplinary engineering team across hardware, software, and systems.
• Drive culture of trust, accountability, and continuous improvement.
• Join R&D Handheld leadership to align PQC strategies with quality and delivery goals.
• Oversee development, integration, and delivery of electromechanical IVD instruments including firmware and data management.
• Collaborate with manufacturing and outsourcing partners for design transfer and production.
• Define KPIs and monitor engineering output, predictability, and reliability.
• Coordinate cross‑functional issues to ensure timely delivery.

Skills

Systems engineering leadership

Hardware‑software integration

Regulatory compliance

Executive presence

Cross‑functional collaboration

Education

Bachelor’s degree in Systems Engineering

Master’s or Ph.D. preferred

Tools

Automated testing frameworks

Requirements management tools

Job description

Siemens Healthineers is seeking a visionary leader to head the Systems Development and Integration team within the Handheld Systems R&D organization. You will bridge hardware and software in POC IVD instruments, guiding a multidisciplinary team and ensuring compliance with FDA, ISO, and IVDR regulations.

This executive role reports to the VP of R&D Handheld Systems and requires strong strategy, risk management, and delivery focus.