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Senior Director, Systems Development and Integration - Handheld Systems

onehealthineers · Yow B

New
Senior 123,500 - 173,500 CAD/year 🇬🇧 English
Systems engineering Requirements engineering Risk management FDA IVDR Automated testing frameworks

Job description

About the role

Siemens Healthineers is looking for a Senior Director to lead its Systems Development and Integration (SDI) team within the Handheld Systems R&D organization. You will report directly to the VP of R&D Handheld Systems and lead a multidisciplinary engineering team behind the Point of Care (POC) Handheld business, which develops and sustains advanced in vitro diagnostic (IVD) instruments. The role bridges complex hardware and diverse software stacks in a regulated environment.

Key responsibilities

  • Manage, mentor and develop a team of people leaders and engineers across hardware, software and systems engineering, fostering trust, accountability and continuous improvement.
  • Serve as a core member of the R&D Handheld leadership team, contributing to the POC business strategy with a focus on quality, compliance and delivery.
  • Oversee the development, integration and delivery of electromechanical IVD instruments, including firmware, embedded software, applications and Instrument Data Management, as well as production tooling.
  • Partner with assay and consumable development teams to ensure seamless hardware-to-consumable integration.
  • Work with internal manufacturing teams and external contract manufacturers to ensure design transfer and scalable production.
  • Drive best practices in requirements engineering, architecture definition and risk management across the product lifecycle.
  • Ensure work meets quality standards and complies with FDA, ISO and IVDR regulations.
  • Define and monitor KPIs for engineering output, predictability and product reliability, and coordinate across functions to remove project impediments.

Required profile

  • Bachelor's degree or higher in Systems Engineering, with a strong foundation in mechanical, electrical and software engineering; a Master's or Ph.D. is strongly preferred.
  • At least 15 years of progressive R&D product development leadership experience in medical devices or IVD.
  • Hands-on systems engineering leadership with full system architecture ownership, requirements management and risk mitigation.
  • Experience managing large, diverse engineering teams, including offshore and global resources.
  • Strong communication, negotiation and influencing skills, and the ability to present technical strategies to senior management.
  • Willingness to travel regularly.

Required skills

  • Knowledge of FDA regulations, ISO 13485 and 14971, and IVDD/IVDR compliance.
  • Advanced systems engineering methodologies and automated testing frameworks for integrated hardware/software systems.
  • Negotiating scope, timelines and resources across competing priorities.

What we offer

  • Expected compensation of $123,500 - $173,500, depending on geography, market, skills, education and experience.
  • Flexible benefits plan, defined contribution pension plan and RRSP matching.
  • Paid time off including vacation, company holidays, sick leave and parental leave (subject to eligibility).

Candidates apply through the Siemens Healthineers careers site; agency resumes are not accepted.

Questions fréquentes

Le salaire proposé pour ce poste est de 124-174k CAD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 2 days ago

Expires 1 month from now

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onehealthineers

Yow B