Systems Engineer – Medical Devices & Design Controls

Coloplast; Humlebæk; Remote; DKK 600,000 - 900,000; Full time

Job summary

Coloplast in Humlebæk, Denmark, is seeking Systems Engineers to join our Systems & Test Engineering team within Product Development. We offer one permanent position and one 12-month maternity cover to strengthen our integrated design control and systems engineering effort, in close collaboration with R&D specialists, Test Engineering, QA, Regulatory Affairs and Project Management.

You will drive design control execution, develop end-to-end system requirements with traceability, participate in

Qualifications

• Degree in engineering or similar technical discipline.
• Experience with systems engineering and design control in regulated environments.
• Knowledge of risk management, requirements engineering, and traceability.
• Experience working cross-functionally with R&D, Test, Quality and Regulatory teams.
• Strong analytical and communication skills.
• Polarion/ALM tools experience is an advantage.

Responsibilities

• 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.

Skills

Systems engineering

Design control

Regulatory awareness

Risk management

Requirements engineering

Traceability

Cross-functional collaboration

Analytical skills

Communication skills

Polarion/ALM tools

Education

Engineering degree

Tools

Polarion

Job description

Coloplast in Humlebæk, Denmark, is seeking Systems Engineers to join our Systems & Test Engineering team within Product Development. We offer one permanent position and one 12-month maternity cover to strengthen our integrated design control and systems engineering effort, in close collaboration with R&D specialists, Test Engineering, QA, Regulatory Affairs and Project Management.

You will drive design control execution, develop end-to-end system requirements with traceability, participate in