Senior Director Systems Development and Integration - Handheld Systems

Siemens Healthineers; Ottawa; On-site; CAD 124,000 - 174,000; Full time

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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

We are seeking a visionary, results-driven leader to head our Systems Development and Integration (SDI) team within the Handheld Systems R&D organization. In this critical role, you will lead a multidisciplinary engineering team dedicated to the Point of Care (POC) Handheld business, which develops and sustains advanced in vitro diagnostic (IVD) instruments for medical testing.

As a key member of the R&D Handheld leadership team reporting directly to the VP of R&D Handheld Systems, you will bridge the gap between complex hardware and diverse software stacks. The ideal candidate possesses a profound systems engineering background, a proven track record of integrating complex devices, and the executive presence to drive strategic execution in a regulated environment.

Key Responsibilities

• Manage, mentor, and develop a high-performing team of people leaders and individual contributors across hardware, software, and systems engineering. Foster a culture of trust, accountability, and continuous improvement.
• Serve as a core member of the R&D Handheld Systems leadership team, contributing to the broader POC business strategy with an unwavering focus on quality, compliance, and delivery.
• Oversee the development, integration, and delivery of electromechanical IVD instruments. This includes direct accountability for all associated software (firmware, embedded, applications, and Instrument Data Management) and production tooling.
• Partner closely with assay and consumable development teams to ensure seamless hardware-to-consumable integration, delivering cohesive, robust solutions for our customers.
• Collaborate with internal manufacturing teams and external contract manufacturing partners to ensure flawless design transfer and scalable production.
• Drive best practices in requirements engineering, architecture definition, and risk management across the entire product lifecycle.
• Ensure all hardware, software, and systems engineering work meets the highest standards of quality, strictly adhering to FDA, ISO, and IVDR regulations.
• Define, monitor, and elevate Key Performance Indicators (KPIs) to measure and improve engineering output, predictability, and product reliability.
• Coordinate across functions to resolve project impediments and ensure timely delivery.

Qualifications

• Bachelor’s degree or higher in Systems Engineering, with a strong multi-disciplinary foundation in mechanical, electrical and software engineering. An advanced degree (Master's or Ph.D.) is strongly preferred.
• Minimum of 15 years of progressive R&D product development leadership experience in the medical device or in vitro diagnostics (IVD) space.
• Demonstrated track record as a hands-on Systems Engineering leader with deep experience integrating complex electromechanical systems - encompassing full system architecture ownership, robust requirements management, and proactive risk identification & mitigation.
• Strong working knowledge of FDA regulations, ISO standards (e.g., 13485, 14971), and IVDD/IVDR compliance.

Leadership & Competencies

• Demonstrated success managing large, diverse engineering teams, including experience leveraging external partnerships and managing significant offshore/global resources.
• Exceptional communication, negotiation, and influencing skills, with a comfortable ability to present complex technical strategies to senior corporate management.
• Proven ability to navigate ambiguity, resolve cross-functional conflict, and prioritize deliverables in a fast-paced, dynamic environment.
• Strong analytical skills with a habit of leveraging data, metrics, and systems principles to make informed decisions and drive performance.
• Willingness to travel regularly, as required

Preferred Knowledge, Skills, And Experience

• Experience leading complex, multi-disciplinary, next-generation platform development projects specifically within the point-of-care IVD space.
• Strong Expertise in advanced systems engineering methodologies and automated testing frameworks for integrated hardware/software systems.
• Demonstrated ability to negotiate scope, timelines, and resource allocation across competing business priorities without compromising quality.

Who we are:

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

The Expected Compensation For This Position Is

$123,500 - $173,500

Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements).

This information is provided per required laws and regulations.

Equal Employment Opportunity Statement:

Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.

Accessibility:

Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. Siemens Healthineers will strive to ensure that policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005.

Siemens Healthineers will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner.