Senior Hardware-ingeniør, Aarhus

VITROLIFE A/S; Aarhus; On-site; DKK 700,000 - 900,000; Full time

Job summary

VITROLIFE A/S i Aarhus søger en erfaren Senior Hardware Engineer, der også kan overtage rollen som Technical Product Owner – Hardware for vores Product Care-team i R&D Medical Devices.

Du får ansvar for hardwarekoordinering, ændringsstyring og samarbejde med udvikling, produktion, forsyningskæde og regulering for at sikre overensstemmelse med MDR, IEC 60601 og FDA.

Qualifications

• Uddannelsesmæssig baggrund som ingeniør eller tilsvarende med stærke analytiske evner.
• 5+ års erfaring med hardware, gerne fra medicinsk industri eller andre regulerede sektorer.
• Bred indsigt og ægte interesse for tværfaglig ingeniørarbejde – elektronik, mekanik, design, proces og produktion.
• Erfaring med root‑cause analyse, produkt- og designændringer.
• Fremragende samarbejdsevner med en struktureret og agil tilgang.
• Flydende dansk og engelsk, skriftligt og mundtligt.
• Kendskab til regulatoriske krav og standarder er en fordel (MDR, IEC 60601, FDA).

Responsibilities

• Tager teknisk ejerskab for hardware og systemsarkitektur til Time Lapse-produkter.
• Driver ændringsstyring og løbende forbedringer i tæt samarbejde med relevante teams.
• Vurderer og implementerer produktændringer baseret på kundefeedback, kvalitetsdata og nye reguleringskrav.
• Gennemgår og opdaterer dokumentation for at sikre overensstemmelse med IEC 60601, MDR og FDA.
• Understøtter produktion og serviceeftersyn.
• Deltager aktivt i prioritering af forbedringer og risikovurdering.

Skills

Hardware engineering

Root-cause analysis

Analytical mindset

Agile collaboration

Regulatory knowledge

Education

Engineering degree or equivalent

Job description

Senior Hardware Engineer – R&D Medical Devices

Seeking an engaged and ambitious Senior Hardware Engineer who can also step into the role of Technical Product Owner – Hardware for our Product Care team in R&D Medical Devices in Aarhus.

Rolle

Responsible for hardware coordination and ongoing improvements of a specific product portfolio focusing on product enhancements, maintenance and compliance. The role ensures product stability and attractiveness throughout its life cycle by coordinating and executing product changes, supporting risk management and collaborating closely with Development, Production, Supply Chain, and Regulatory teams.

Ansvar

• Takes technical ownership of hardware and system architecture for our Time Lapse products.
• Drives change management, ongoing improvements and root‑cause analysis in close collaboration with relevant teams.
• Assesses and implements product changes based on customer feedback, quality data and new regulatory requirements.
• Reviews and updates documentation to ensure compliance with standards such as IEC 60601, MDR and FDA.
• Supports ongoing production and aftersales support.
• Actively participates in prioritization of improvements and risk assessment.

Kvalifikationer

• Educational background as an engineer or similar with strong analytical skills.
• 5+ years experience with hardware, preferably from medical industry or other regulated sectors.
• Broad insight and genuine interest in multidisciplinary engineering work – electronics, mechanics, design, process and production.
• Experience with root‑cause analysis, product and design changes.
• Excellent collaboration skills with a structured and agile approach.
• Fluent in Danish and English, written and spoken.
• Motivated by technical challenges.
• Knowledge of regulatory requirements and standards is an advantage (MDR, IEC 60601, FDA).

Personlige egenskaber (Du er)

• Strong communicator who can convey technical matters clearly to both technical and non‑technical colleagues.
• Analytical mindset – enables effective resolution of technical challenges.
• Team player contributing collaboration and support in multidisciplinary teams.
• Solution oriented – identifies and solves challenges proactively.
• Structured and organized – ensures solid documentation and follow‑up on key tasks.
• Flexible and open to change – maintains a positive attitude toward continuous improvement.
• Owns and takes responsibility for deliverables and deadlines.
• Capable of handling multiple tasks and prioritizing effectively in a dynamic environment.
• Motivated by helping others and contributing to shared success.

Succes i rollen

• Ensures existing hardware and Time Lapse systems are updated, robust and fully compliant with legal requirements.
• Product changes and improvements are implemented effectively and well documented.
• Becomes subject matter expert for existing products and processes, supporting business during audits and compliance activities.
• Contributes to strong collaboration with colleagues in QA, Regulatory, Production and Aftersales so the product meets both customer and business needs.

Lokation

Aarhus