Senior Director Systems Development and Integration - Handheld Systems

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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 advancedin vitrodiagnostic (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:

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.


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