Lead System Designer

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

Job Description Summary

As a Lead System Designer, you will provide technical leadership across the full product lifecycle, ensuring that product 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. You will lead technical reviews, drive resolution of technical issues, and help teams make informed technical decisions while balancing performance, quality, schedule, and regulatory requirements. For this role, you must be eligible to work in Denmark and on-site our facilities in Herlev, near Copenhagen.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Essential 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.

Required Qualifications

• Relevant Engineering degree.
• 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.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.

Additional Information

Relocation Assistance Provided: No. At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.