3 Π΄Π½Ρ Π½Π°Π·Π°Π΄
Lead Usability Engineer (Medical Devices)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Lead Usability Engineer (Medical Devices): Driving usability engineering compliance and developing lifecycle processes for advanced hearing devices with an accent on IEC 62366, FDA Human Factors Engineering guidance, and regulatory documentation. Focus on leading usability activities, supporting submissions and audits, and solving complex human factors challenges for user-centered medical products.
Location: Ballerup, Denmark; flexible hybrid working with in-person collaboration when needed
Company
develops hearing, audio, video, and gaming solutions, including intelligent hearing devices that help people overcome communication challenges.
What you will do
- Drive regulatory product compliance in usability engineering for new product development.
- Establish, maintain, and improve usability engineering processes and documentation across the product lifecycle.
- Act as the lead usability specialist and subject-matter expert.
- Support regulatory submissions, audits, and responses to authorities related to usability and human factors engineering.
- Collaborate with Post-Market Surveillance, Vigilance, and Usability Engineering specialists to deliver compliant, user-centered hearing products.
Requirements
- Relevant academic background in engineering or a related field.
- Solid direct experience in usability engineering within a medical device environment.
- Working knowledge of IEC 62366 and/or FDA Human Factors Engineering guidance.
- Experience with usability engineering for complex and technologically advanced medical devices.
- Confident, credible communication skills and the ability to influence stakeholders with different levels of regulatory and usability knowledge.
- Proficient written and spoken English is required.
Culture & Benefits
- Flexible working is supported whenever possible.
- Collaborative, supportive, and quality-driven working environment.
- Opportunity to help mature the usability engineering framework for an evolving product roadmap.
- Inclusive recruitment process with equal consideration for all applicants.
- Applicants may request special interview accommodations.
Hiring process
- Submit an up-to-date CV and a few sentences describing motivation through the application link by September 27, 2026.
- Applications are assessed continuously, and the position may close before the stated deadline once a candidate is hired.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β