Lead System Designer - Medical Devices, Technical Leader

HC1374 BK Medical ApS; Herlev Kommune; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

GE HealthCare in Denmark 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 guide technical decisions within cross-functional teams, drive design verification and validation, manage risk assessments and FMEA, and support design transfer to manufacturing and service organizations at our Herlev facilities near Copenhagen.

Qualifications

• Engineering degree in a relevant field.
• Experience in medical devices or regulated industry.
• Knowledge of Design Control, Risk Management, Verification, Validation.
• Experience leading complex product development across multiple engineering disciplines.
• Experience collaborating across software, electrical, mechanical, manufacturing, service, clinical, and quality functions.

Responsibilities

• Provide technical leadership across the product lifecycle in NPI and sustaining programs.
• Lead technical decisions and product design directions in cross-functional teams.
• Review and approve requirements for feasibility and traceability.
• Define and drive Design Verification and Design Validation strategies.
• Lead Technical Design Reviews and issue resolution.
• Oversee risk assessments, FMEA, and risk-control integration.
• Support design transfer to manufacturing and service organizations.

Skills

Systems Engineering

Technical Leadership

Design Control

Risk Management

Verification & Validation

FMEA

Cross-functional Leadership

Documentation

Education

Engineering degree

Job description

GE HealthCare in Denmark 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 guide technical decisions within cross-functional teams, drive design verification and validation, manage risk assessments and FMEA, and support design transfer to manufacturing and service organizations at our Herlev facilities near Copenhagen.