Senior Requirements Engineer (Medtech)

TL;DR

Senior Requirements Engineer (Medtech): Leading and evolving requirements engineering discipline for assistive communication solutions with an accent on system decomposition, traceability, and regulatory compliance. Focus on optimizing ALM tooling, driving continuous process improvement, and aligning cross-functional teams across the full product lifecycle.

Location: Stockholm

Company

A global leader in assistive communication solutions dedicated to empowering individuals with disabilities through innovative technology.

What you will do

• Define system and subsystem requirements ensuring completeness, clarity, consistency, and regulatory compliance.
• Own and improve requirements management practices and bidirectional traceability processes.
• Drive implementation and governance of requirements and ALM tooling to support efficient development.
• Collaborate with product, quality, UX, hardware, software, and operations teams.
• Ensure requirements alignment, architectural clarity, and verification readiness.

Requirements

• Bachelor’s or Master’s degree in Systems Engineering, Electrical Engineering, Software Engineering, or related technical field.
• Strong experience in requirements engineering, system decomposition, and traceability management for medical devices.
• Hands-on systems engineering experience with both hardware and software in linear and agile development frameworks.
• Proven ability to design and execute system verification activities and acceptance criteria.
• Proficiency with ALM tools such as Polarion, Jama, DOORS, or Codebeamer.
• Fluent in Swedish and English, both written and spoken.

Nice to have

• INCOSE SEP certification.
• SAFe Practitioner or Architect certification.
• Knowledge of regulated frameworks such as ISO 13485, IEC 62304, ISO 14971, FDA QSR, EU MDR, and ISO 15288.
• Experience implementing or migrating ALM or requirements management tools.

Culture & Benefits

• Global company culture focused on empowerment and impactful purpose.
• Commitment to collaboration and welcoming individuality.
• Opportunities to innovate with the latest technology in assistive communication.
• Flexible work environment and focus on work-life balance.
• Equal opportunity employer dedicated to diversity and inclusivity.