Director of Product Development & Systems Engineering
About Wellumio
Wellumio is a venture-backed medical device company on a mission to empower timely stroke intervention with rapid, point-of-care diagnostics.
Magnetic resonance is the gold standard in medical imaging for acute stroke. Yet access is constrained by high costs, heavy infrastructure, and the need to move patients to fixed scanners. Instead of bringing patients to the scanner, Wellumio is building technology that brings the scanner to the patient.
Wellumio’s MRI-based brain imaging system, Axana®, is a portable, energy-efficient scanner designed for point-of-care use in emergency departments, rural hospitals, and pre-hospital settings. Its first application is acute stroke, one of the leading causes of death and disability worldwide, where every minute of delay to treatment leads to further brain injury and worse long-term outcomes.
By removing traditional barriers to diagnostic imaging and embedding Axana directly into frontline stroke workflows, Wellumio aims to enable earlier diagnosis, faster treatment, and better outcomes for patients globally.
At Wellumio you will:
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Work with a talented, mission-driven team across medicine, engineering, and commercial disciplines.
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Help build a novel point-of-care brain imaging technology from the ground up.
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Operate in a fast-paced environment that rewards initiative, clear thinking, and impact.
At Wellumio we're challenging dominant models of clinical service delivery by fusing technology, design innovation, medical expertise, and systems-level thinking to create imaging solutions that put the needs of patients first.
Key Responsibilities
Product Development Leadership
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Own and continuously improve Wellumio's product development operating model.
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Establish and maintain product roadmaps, technology roadmaps, and development plans aligned with company strategy, product objectives, and commercialization goals.
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Develop organizational capability through leadership, mentoring, coaching, governance, process improvement, systems engineering practices, and cross-functional collaboration.
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Ensure alignment between product strategy, development execution, quality systems, regulatory requirements, and business objectives.
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Drive development processes that support predictable execution, technical excellence, and successful commercialization.
Integrated Management System Leadership
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Own the architecture, integration, effectiveness, and continuous improvement of Wellumio's Integrated Management System (IMS).
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Ensure alignment between product development processes, quality management, information security, risk management, regulatory compliance, and organizational governance.
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Establish and maintain management system frameworks supporting ISO 13485, cybersecurity, privacy, AI governance, and future regulatory requirements.
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Ensure management systems support efficient product development, regulatory compliance, operational scalability, and commercialization.
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Drive continuous improvement through performance metrics, audits, management reviews, risk assessments, CAPAs, and organizational learning.
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Maintain coherence across management systems while enabling appropriate functional ownership and accountability.
Systems Engineering & Technical Governance
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Establish and maintain systems engineering frameworks and integration processes supporting multidisciplinary product development.
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Ensure product requirements, architecture, interfaces, technical risks, and verification activities are managed coherently across all engineering disciplines.
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Define and maintain Technical Performance Measures (TPMs) and development metrics used to assess product maturity, technical risk, and development progress.
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Facilitate architecture reviews, design reviews, technical governance forums, and development decision-making processes.
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Ensure development activities and technical decisions remain aligned with product objectives, regulatory requirements, and commercialization goals.
Program Planning & Development Execution
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Maintain integrated product development plans linking roadmaps, schedules, resources, budgets, and engineering execution.
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Establish governance mechanisms supporting development predictability, accountability, and delivery performance.
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Monitor development progress, technical risks, resource constraints, and organizational dependencies.
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Provide objective development status, forecasts, metrics, risks, and decision-support information to executive leadership.
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Coordinate execution across multidisciplinary teams, external partners, suppliers, and contractors.
Quality, Regulatory & Risk Integration
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Ensure product development activities operate effectively within the Integrated Management System and Quality Management System.
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Integrate design controls, risk management, verification, validation, usability engineering, cybersecurity, clinical activities, and regulatory requirements into product development processes.
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Partner with quality, regulatory, and clinical functions to ensure compliance while maintaining development efficiency and product quality.
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Support audits, regulatory submissions, certifications, and external assessments as required.
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Ensure development outputs are suitable for regulatory approval, market authorization, and commercial deployment.
Commercialization & Product Readiness
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Ensure products are developed with consideration for manufacturability, serviceability, supportability, cybersecurity, scalability, reliability, and lifecycle management.
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Identify technical, organizational, supplier, process, and operational risks that may impact successful commercialization.
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Support transition from research and development through pilot manufacturing, verification, validation, and commercial release.
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Ensure development activities support long-term product sustainability, operational readiness, and business growth.
Soft Skills Requirements
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Strong problem-solving and analytical skills
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Ability to work independently and as part of a team
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Good communication and collaboration skills
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Willingness to learn and continuously develop technical expertise
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Professionalism, reliability, and attention to detail
About the Role
The Director, Product Development & Systems Engineering is accountable for the successful development and delivery of Wellumio's MR-based stroke diagnostic products from concept through commercialization.
The role provides leadership across product development, systems engineering integration, integrated management systems, program execution, quality integration, risk management, verification planning, cybersecurity, and commercialization readiness. The position ensures that product strategy, engineering execution, quality systems, regulatory requirements, and business objectives are aligned within a coherent and scalable product development framework.
The role is accountable for delivering products while simultaneously building the organizational capability required to repeatedly deliver successful products through effective product development processes, systems engineering practices, governance frameworks, and management systems.
Operating in a matrix leadership capacity, the Director works collaboratively across engineering, science, quality, regulatory, clinical, manufacturing, and commercial functions to improve organizational capability, development predictability, product quality, and commercialization outcomes.
People & Organisational Leadership
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Talent Development & Mentorship: Actively mentor engineering and project leads to develop their technical and leadership capabilities. Create structured career development pathways for the development team to ensure retention and growth.High-Performance Culture: Foster a culture of accountability, transparency, and psychological safety. Act as a change agent in shifting the team from "task completion" to "ownership-based delivery."
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Conflict Resolution & Matrix Management: Serve as the primary mediator for cross-functional friction. Navigate complex interpersonal dynamics across engineering, regulatory, and commercial teams to maintain organisational alignment.
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Knowledge Transfer Strategy: Implement a formalised knowledge-sharing framework to capture institutional memory and reduce "key-person dependency," ensuring the organisation remains resilient even during leadership or staff turnover.
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Succession Planning: Identify and nurture high-potential talent within the technical organisation to ensure a sustainable pipeline of future leaders.
Key Outcomes
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Successful delivery of product development programs and commercialization milestones.
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Predictable execution against schedule, budget, quality, and technical objectives.
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Effective operation and continuous improvement of the Integrated Management System.
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Increased visibility of technical maturity and risk through TPMs and governance metrics.
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High-quality verification, validation, and regulatory readiness outcomes.
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Increased organizational capability, development effectiveness, and operational scalability.
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Successful transition from development to manufacturing, regulatory approval, and commercial deployment.
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Achievement of company product and commercialization objectives.