Engineering Director - Digital Diagnostics

Overview

Lead end-to-end development of digital diagnostic devices and connected systems.

Key Responsibilities

• design transfer
• digital integration
• ai architecture
• connected systems
• design control
• npd execution

Tasks

-Partners cross-functionally with Regulatory, Quality, and Operations to ensure successful design transfer and post-market support. -Maintains awareness of emerging technologies, digital health regulations, and competitive trends to inform strategic decisions. -Participates in enterprise-level innovation and technology planning initiatives. -Collaborates with Product Management and Clinical Affairs to translate clinical requirements and user needs into engineering specifications. -Partners with software engineering, clinical affairs, and IT security to ensure seamless integration of device data into digital platforms and EHR systems. -Drives continuous improvement initiatives in design processes, digital toolchains, and system validation methodologies. -Develops and mentors high-performing teams of engineers and technical managers focused on digital diagnostics and connected systems. -Leads system architecture decisions for AI-enabled diagnostic products, leveraging data science and machine learning where applicable. -Directs the engineering design and development of connected diagnostic systems, including sensors, firmware, data acquisition, and digital interfaces. -Defines and implements digital design control best practices, including verification, validation, cybersecurity, and risk management. -Drives execution of the NPD process, ensuring project timelines, budgets, and technical deliverables are met. -Leads and oversees all phases of new product development (NPD) for digital diagnostic solutions, from concept through commercialization, ensuring compliance with FDA, ISO 13485, and ISO 14971 standards. -Oversees supplier development and external partnerships for digital hardware, software, and component technologies. -Represents the organization in technical partnerships, regulatory audits, and professional forums.

Requirements

• systems engineering
• product development
• software lifecycle
• digital design
• regulatory compliance
• plm

What You Bring

-Expert knowledge of new product development methodologies and systems engineering -Strategic thinker with strong business acumen and innovation mindset -Comprehensive understanding of software development lifecycle and connected device integration -Demonstrated ability to develop talent and foster cross-functional collaboration -Expert knowledge of digital system design, medical electronics, and diagnostic instrumentation -Solid working knowledge of design controls, risk management, and regulatory compliance (FDA, IEC 60601, ISO 13485, ISO 14971, cybersecurity standards) -Comprehensive leadership, communication, and organizational skills -Proficient in digital engineering tools, PLM, and ERP systems

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About Midmark Corporation

-Designs and manufactures medical equipment that enhances the patient care experience. -Offers a wide range of products including examination tables, diagnostic equipment, and sterilization systems. -Serves various healthcare facilities like hospitals, clinics, and dental offices with tailored solutions. -Known for innovative products that improve workflows and patient outcomes in medical environments. -Has a global presence with operations extending across multiple countries and healthcare markets. -Consistently focused on integrating cutting-edge technology into their products for efficiency and safety.

Sector Specialisms