Senior System Designer - Medical Devices, On-Site Denmark

GE HealthCare; Herlev Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

GE HealthCare is seeking a Lead System Designer to provide technical leadership across the full product lifecycle, ensuring designs meet customer needs, business objectives, quality expectations, and regulatory requirements.

You will lead technical decision-making within cross-functional teams and support the integration of requirements, risk management, verification, validation, and design transfer activities.

Qualifications

• Significant experience in Systems Engineering, Product Development, or Technical Leadership within medical devices or another regulated industry.
• Strong understanding of Design Control, Risk Management, Verification, Validation, and Change Control.
• Experience leading complex product development activities across multiple engineering disciplines.

Responsibilities

• Provide technical leadership within NPI and sustaining engineering programs throughout the product lifecycle.
• Serve as the technical lead within cross-functional teams, guiding technical decisions and product design direction.
• Review and approve product requirements are complete, feasible, testable, and aligned with customer and business needs.
• Accountable for development of system requirements and related Design Control deliverables.
• Define and drive Design Verification and Design Validation strategies.
• Lead Technical Design Reviews and resolution of technical issues.
• Lead defect management, technical investigations, and problem solving.
• Review and support risk assessments and FMEA activities, drive FMEA strategy ensuring effective integration of risk controls into product requirements, verification, and validation.
• Ensure traceability between customer needs, requirements, risks, verification and validation evidence.
• Support Design Transfer and technical knowledge transfer to manufacturing and service organizations.

Skills

Systems engineering leadership

Design Control

Cross-functional collaboration

Technical writing

Communication

Education

Engineering degree

Job description

GE HealthCare is seeking a Lead System Designer to provide technical leadership across the full product lifecycle, ensuring designs meet customer needs, business objectives, quality expectations, and regulatory requirements.

You will lead technical decision-making within cross-functional teams and support the integration of requirements, risk management, verification, validation, and design transfer activities.