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We are looking for 2 Systems Engineers for 1 permanent position and 1 12-months temporary position to strengthen our combined Systems & Test Engineering team in Product Development at Coloplast. The role supports ongoing development by driving systems engineering and design control execution in close collaboration with R&D specialists, Test Engineering, QA, Scientific Affairs, Regulatory Affairs, and Project Management.
Job Responsibility:
Drive and support design control and product risk management activities in development projects
Translate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability
Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation
Support design verification and validation planning and execution in close collaboration with Test Engineering
Participate in design reviews, change control, and impact assessments
Ensure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971)
Collaborate closely with cross-functional project teams to support timely project execution
Requirements:
Degree in engineering or a similar technical discipline
Experience with systems engineering and design control in a regulated environment (medical devices are an advantage)
Knowledge of risk management, requirements engineering, and traceability
Experience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders
Strong analytical and communication skills
Experience with Polarion or similar ALM tools is an advantage