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Systems Engineer II

repligen · Tallinn

Nouveau
🇬🇧 English
CAD PDM/PLM platforms risk management FMEA design controls single-use systems bioprocess equipment automation integration

Description du poste

About the role

The Systems Engineer II is an individual contributor in the R&D organization, leading engineering execution and technical coordination of Engineer-to-Order custom system projects. The role acts as the technical focal point for customer‑specific solutions, translating requirements into robust deliverables while ensuring compliance with quality, regulatory and business standards.

Key responsibilities

  • Develop and maintain engineering documentation, specifications, risk assessments and change‑control records in line with design control requirements.
  • Support verification, testing and customer acceptance activities to confirm performance and quality.
  • Apply systems engineering and risk management principles throughout the product lifecycle.
  • Partner with Product Management, Quality, Operations, Supply Chain, Service and Commercial teams to ensure successful project delivery.
  • Facilitate communication and alignment across mechanical, electrical, process, automation engineering and other stakeholders.
  • Contribute to continuous improvement initiatives and evolution of standard products based on lessons learned from custom projects.

Required profile

  • Bachelor’s or Master’s degree in Engineering, Life Sciences or a related technical discipline.
  • Experience coordinating multidisciplinary engineering projects within stage‑gate product development and manufacturing environments.
  • Knowledge of design controls, risk management, FMEA and engineering documentation practices.
  • Experience with single‑use systems, bioprocess equipment, GMP‑regulated environments and automation integration is strongly preferred.

Required skills

  • Proficiency with CAD and PDM/PLM platforms.
  • Strong understanding of risk management and FMEA methodologies.
  • Familiarity with design control documentation and change‑control processes.

What we offer

  • Competitive remuneration package with yearly bonus.
  • Additional health insurance, sport benefits and flexible working hours.
  • Fast‑paced, stimulating environment with steep learning curves.
  • Opportunity to contribute to global healthcare impact.

Questions fréquentes

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Source : ats:workday

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