Senior Systems & Usability Engineer for °MEQU

MEQU Warmer Systems Corp.; København; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

MEQU is growing its R&D team and seeks a Senior Systems & Usability Engineer to connect user needs, system requirements, risk management and verification across the °M Warmer System.

Based in Copenhagen, you will influence regulatory documentation, design reviews and usability activities, working with cross-functional teams to ensure safe, intuitive medical devices used worldwide. CE/FDA experience is advantageous.

Qualifications

• Bachelor's or master's in engineering or related technical field.
• Several years of engineering experience in systems or usability engineering for medical devices.
• Experience with requirements engineering and traceability.
• Knowledge of design control, risk management and medical-device product development.
• Knowledge of IEC 62366 and ISO 14971.
• Strong analytical, technical and documentation capabilities.
• Strong communication across technical disciplines.
• User-focused, quality-driven product development mindset.
• Experience with FDA-regulated devices, CE marking/MDR, usability validation or human factors engineering is a bonus.

Responsibilities

• Define, structure and manage system requirements and support decomposition.
• Translate user needs into clear, testable product and system requirements.
• Maintain end-to-end traceability between user needs, requirements, risks, design outputs and verification evidence.
• Support system architecture, interface definition and technical decision-making.
• Plan, lead and document usability-engineering activities per IEC 62366.
• Plan and conduct formative usability evaluations and support summative validation.
• Contribute to use-related risk analysis and align usability with ISO 14971.
• Prepare and maintain usability-engineering documentation and other design-control deliverables.
• Support design reviews, changes, verification activities and regulatory submissions.
• Collaborate across R&D, Quality, Regulatory Affairs and external stakeholders; help evolve processes.

Skills

Systems engineering

Usability engineering

Medical-device development

Regulatory knowledge

Documentation skills

Education

Bachelor's or Master's degree in engineering

Job description

Help turn user needs into safe, effective and compliant medical devices

°MEQU is growing, and we are expanding our R&D team with three new engineering positions.

We are looking for an experienced Senior Systems & Usability Engineer who wants to take a central role in connecting user needs, system requirements, risk management, verification and usability engineering throughout the development of our °M Warmer System – a portable blood and IV fluid warmer used in critical care settings around the world.

This is a newly created role with broad influence across the R&D value chain. You will work close to both users and technology, helping ensure that our products are not only technically robust, but also safe, intuitive and effective in real clinical environments.

The position is one of three new engineering roles being added to our R&D team. You can also find the other positions on the °MEQU website and LinkedIn:

• Senior Verification Engineer
• Senior Electronics & Embedded Software Engineer

At °MEQU, our mission is to empower healthcare professionals to fight hypothermia and save lives.

Our °M Warmer System heats blood and IV fluids to body temperature within seconds and is used by military forces, emergency services and hospitals internationally.

The product has been CE-marked since 2018 and received FDA 510(k) clearance in 2024. We are now entering the next stage of our development, scaling the company and expanding into new international markets.

Our Danish office is located at Symbion, Fruebjergvej 3, 2100 Østerbro, Copenhagen.

Joining °MEQU means becoming part of an experienced and highly engaged R&D team working across the full medical-device product lifecycle – from user needs and system definition through development, verification, regulatory documentation and products in the market.

THE ROLE

As our Senior Systems & Usability Engineer, you will help create the link between users, product requirements, technical solutions, risk management and verification.

You will own and develop key systems-engineering and usability-engineering activities and deliverables, ensuring that user needs are translated into clear, traceable and verifiable requirements and that usability is addressed systematically throughout product development.

The role combines structured systems engineering and regulatory documentation with practical collaboration across R&D. You will work closely with engineering, Quality and Regulatory colleagues and contribute to technical decisions, design reviews and product improvements.

Because °MEQU is a growing company, you will also have the opportunity to influence how our systems-engineering and usability capabilities, processes and tools develop as the organization grows.

YOUR KEY RESPONSIBILITIES

Define, structure and manage system requirements and support requirements decomposition.

Translate user needs and intended use into clear, testable product and system requirements.

• Maintain end-to-end traceability between user needs, requirements, risks, design outputs and verification evidence.
• Support system architecture, interface definition and technical decision-making across disciplines.
• Plan, lead and document usability-engineering activities in accordance with IEC 62366.
• Plan and conduct formative usability evaluations and support summative usability validation.
• Contribute to use‑related risk analysis and ensure alignment between usability engineering and ISO 14971 risk‑management activities.
• Prepare and maintain usability‑engineering documentation and other system-level design‑control deliverables.
• Support design reviews, design changes, verification activities and regulatory submissions.
• Collaborate with R&D, Quality, Regulatory Affairs and relevant external stakeholders to resolve system-level and usability issues.Contribute to the continued development of °MEQU’s systems‑engineering and usability processes, templates and ways of working.

ABOUT YOU

You are an experienced engineer who enjoys seeing the whole product rather than only one technical discipline. You can move between user needs, technical requirements, risk, documentation and practical product‑development decisions.

You have several years of relevant experience in systems engineering, usability engineering, medical‑device development or a closely related field. Experience from MedTech is highly relevant, although strong experience from another technically complex and regulated industry may also be a good fit.

Experience from a growing or changing organization is an advantage. Most important is that you are comfortable working in an environment where structures are developing and where experienced engineers are expected to contribute to how things should be done.

QUALIFICATIONS

We expect you to have:

• A bachelor’s or master’s degree in engineering or a related technical discipline.
• Several years of relevant engineering experience.
• Experience with requirements engineering and requirements traceability.
• Knowledge of design control, risk management and medical‑device product development.
• Knowledge of IEC 62366 and ISO 14971.
• Strong analytical, technical and documentation capabilities.
• Strong communication skills and the ability to work across technical disciplines.
• A user‑focused and quality‑driven approach to product development.
• Experience with FDA-regulated medical devices, CE marking/MDR, usability validation, human factors engineering or formal systems‑engineering methods will be an advantage.

HOW YOU WORK

• Are a hands‑on problem solver with a structured and analytical approach.
• Can maintain the system‑level overview while still engaging with technical detail.
• Ask the questions that connect user needs, risks, requirements and design decisions.
• Take ownership and follow activities and documentation through to completion.
• Proactively collaborate with colleagues across R&D and other functions.
• Communicate complex technical topics clearly and pragmatically.
• Are comfortable in a flexible environment where priorities and structures evolve.
• Enjoy having influence and responsibility rather than working within narrowly defined boundaries.

WHAT WE OFFER

At °MEQU, you will get:

• A key systems role in a growing international MedTech company.
• The opportunity to work with products that make a real difference in critical care.
• Close collaboration with highly skilled engineering and MedTech specialists.
• Exposure to the full R&D and medical‑device product lifecycle.
• The opportunity to shape how systems engineering and usability engineering are practiced.

A working environment with professional ambitions, collaboration, continuous learning and a strong

As °MEQU continues to grow, your role may evolve with the company – and we see that as an opportunity.