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Senior Project Manager – Medical Devices

Critical Software · Lisbonne

Senior 🇬🇧 English
IEC 62304 ISO 13485 MDR SaMD SiMD

Job description

About the role

You will lead end‑to‑end delivery of medical device projects, ensuring compliance with quality and safety standards while coordinating cross‑functional teams, clients, and regulatory stakeholders. The role is based in one of our Portuguese offices (Lisbon, Coimbra, Viseu or Porto) and requires strong leadership in a safety‑critical environment.

Key responsibilities

  • Manage scope, timelines, budget, risks and stakeholder expectations throughout the project lifecycle.
  • Coordinate software, hardware, and systems engineering teams with quality and regulatory experts.
  • Maintain traceability, documentation and risk management aligned with IEC 62304, ISO 13485, FDA and MDR requirements.
  • Drive continuous improvement and adopt best practices in medical device development.
  • Mentor team members and foster a culture of quality, safety and excellence.
  • Support business development activities and client relationship growth in the medical‑devices domain.

Required profile

  • 5+ years (ideally 7+) of experience managing complex projects, preferably in medical devices.
  • Strong leadership and decision‑making in safety‑critical contexts.
  • Excellent communication skills with both technical and non‑technical stakeholders.
  • Fluent English (C1/C2 level).

Required skills

  • Agile, Waterfall or Hybrid project‑management methodologies.
  • Regulatory standards: IEC 62304, ISO 13485, FDA, MDR.
  • Knowledge of software for medical devices (SaMD / SiMD).
  • Experience with validation, verification and clinical considerations.

What we offer

  • Private health insurance and Employee Assistance Programme.
  • Home‑office support and extra holidays after the first year.
  • Additional parental leave and gradual return‑to‑work support.
  • Sabbatical programme, training, mentorship and growth opportunities.

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Published 3 months ago

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Critical Software

Lisbonne