Senior Director Systems Development and Integration - Handheld Systems

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.

• 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.

• Education & Experience 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.

• 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…