Interim VP of R&D Engineering Diagnostics​/Med Device

Position Overview

Our client is seeking an experienced and hands-on Interim VP of R&D;
Engineering to lead the company’s innovation strategy and product development initiatives across integrated diagnostic platforms. This executive leader will oversee the development of instruments, consumables, assays, software, and enabling technologies while driving execution across the full product lifecycle. The Vice President of R&D;
Engineering will be responsible for delivering scalable, manufacturable, and high-performance diagnostic solutions that meet clinical, regulatory, and commercial requirements. This role requires deep technical leadership within regulated medical device and diagnostics environments combined with the ability to operate effectively in a fast-paced, high-growth organization.

• 15+ years of progressive R&D; and engineering leadership experience within diagnostics, medical devices, IVD, point-of-care diagnostics, or life science instrumentation.
• Proven success launching complex integrated diagnostic systems involving instruments, consumables, assays, and software platforms.
• Deep expertise in design controls, risk management, systems engineering, verification & validation (V&V;), and full product development lifecycle management.
• Strong knowledge of FDA, ISO, and global regulatory standards applicable to diagnostics and medical devices.
• Demonstrated ability to lead within fast-growing, high-ambiguity, scale-up environments.
• Strong executive communication and cross-functional leadership capabilities.
• Experience supporting technology transfer and manufacturing scale-up activities.
• Experience leading globally distributed engineering and product development teams.

• Interim leadership opportunity with strong potential for long-term conversion.
• Highly visible executive leadership role within a growing diagnostics organization.
• Must be able to work onsite in the Greater Toronto Area approximately 70% initially.

• Define and execute the company’s R&D; and engineering strategy across diagnostic instruments, consumables, assays, software, and enabling technologies.
• Lead multidisciplinary engineering and scientific teams across mechanical engineering, electrical engineering, firmware, systems engineering, assay chemistry, consumables development, optical engineering, and UX/human factors.
• Own the full product lifecycle from concept, architecture, feasibility, and development through design freeze, verification & validation (V&V;), technology transfer, manufacturing readiness, and commercialization.
• Drive execution of design controls ensuring compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and global IVD and diagnostic regulatory requirements.
• Oversee risk management activities, usability engineering, test method development, verification, and validation strategies.
• Ensure requirements, product specifications, systems architecture, traceability, and documentation are robust, complete, and risk-responsive.
• Partner cross-functionally with Quality, Regulatory, Manufacturing, Clinical, Operations, and Commercial leadership teams.
• Support scalable product development processes appropriate for a rapidly growing diagnostics organization.
• Mentor and develop engineering leadership teams while driving accountability, execution, and innovation.