Senior System Designer, Medical Devices Lead Design Control

GE HealthCare; København; On-site; DKK 900,000 - 1,300,000; 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 reviews, guide decisions within cross-functional teams, and support the integration of requirements, risk management, verification, 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.
• Extensive experience working across software, electrical, mechanical, manufacturing, service, clinical, and quality functions.
• Extensive experience developing requirements, specifications, verification strategies, and technical documentation.
• Demonstrated ability to influence technical decisions across cross-functional teams.
• Strong problem-solving, communication, and technical writing skills.

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

Product Development

Technical Leadership

Medical devices

Design Control

Risk Management

Verification & Validation

Change Control

Cross-functional collaboration

Technical documentation

Education

Engineering degree

Tools

FMEA

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 reviews, guide decisions within cross-functional teams, and support the integration of requirements, risk management, verification, and design transfer activities.