Senior Requirements Engineer (Medtech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Requirements Engineer (Medtech): Leading and evolving requirements engineering discipline across the full product lifecycle for assistive communication solutions with an accent on traceability, compliance, and ALM tooling optimization. Focus on driving continuous improvement of requirements processes and collaborating across cross-functional teams to ensure verification readiness in a regulated medical device environment.
Location: Stockholm (Onsite)
Company
A global leader in assistive communication solutions dedicated to empowering people with disabilities to express themselves and connect with the world.
What you will do
- Lead requirements development by defining system and subsystem requirements derived from stakeholder and user needs.
- Own and improve requirements management practices, including bidirectional traceability across the product lifecycle.
- Drive the implementation, optimization, and governance of requirements and ALM tools.
- Collaborate with Product, Quality, Regulatory, UX, Hardware, and Software teams to ensure alignment and verification readiness.
- Coach and support project team members in delivering on their requirements engineering responsibilities.
Requirements
- Bachelor’s or Master’s degree in Systems, Electrical, or Software Engineering, Computer Science, or related field.
- Strong hands-on experience with requirements engineering and traceability management for medical devices.
- Proven experience in systems engineering roles involving both hardware and software in linear and agile frameworks.
- Experience with ALM tools such as Polarion, Jama, DOORS, or Codebeamer.
- Fluent in Swedish and English, both written and spoken.
Nice to have
- Knowledge of regulated frameworks such as ISO 13485, IEC 62304, ISO 14971, FDA QSR, EU MDR, and ISO 15288.
- INCOSE SEP certification.
- SAFe certification or strong background in Agile environments.
- Prior experience implementing or migrating ALM or requirements tools.
Culture & Benefits
- Work in a dynamic, global company with a clear, impactful purpose.
- Collaborative work culture where individuality is welcomed.
- Opportunity to innovate using the latest technology on leading platforms.
- Focus on work-life balance with flexibility outside of work.
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