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Systems Engineer II - ETO Custom Systems

Repligen Corporation · Comté de Harju

Nouveau
Mid 🇬🇧 English
CAD PDM PLM FMEA Design controls

Description du poste

About the role

The Systems Engineer is an individual contributor within the R&D organization, responsible for leading the engineering execution and technical coordination of Engineer-to-Order (ETO) custom system projects. As the technical focal point for customer-specific solutions, the engineer ensures customer requirements are turned into robust engineering deliverables while meeting quality, regulatory and business requirements. The role reports to the Sr. Manager – Systems Engineering & Lifecycle Management.

Key responsibilities

  • Evaluate customization requests for technical feasibility, compliance, cost, schedule, risks and impact on standard products.
  • Translate customer needs into clear engineering deliverables and coordinate activities across mechanical, electrical, automation and process engineering.
  • Support technical customer discussions, design reviews, risk assessments and change requests.
  • Lead the development of custom / ETO projects.
  • Work with Mechanical, Electrical, Process and Automation Engineering teams, as well as Product Management, Quality, Operations, Service, Supply Chain and Commercial functions.

Required profile

  • Bachelor's or Master's degree in Engineering, Life Sciences or a related technical discipline.
  • Experience coordinating multidisciplinary engineering projects and working in 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 engineering documentation and product data management tools, including CAD and PDM/PLM platforms.

What we offer

  • A competitive remuneration package including a yearly bonus.
  • An additional health insurance package and sport benefits.
  • Flexible working hours.
  • A fast-paced, international team and a modern office in Jüri, Estonia.

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Repligen Corporation

Comté de Harju