Hybrid Medical Device Validation & Risk Engineer

Novocure Inc.; Poland; Hybrid; PLN 192,000 - 204,000; Full time

Benefits offered by this job

Life Insurance

Performance Bonus

Private Medical Care

...and more!

Job summary

Novocure Inc. seeks a Process Validation Engineer to join the Operations Engineering team in a hybrid role from Cracow. You will lead validation and risk activities to ensure quality and regulatory compliance in a global medical device environment.

You will manage validation programs, risk documentation, audits, and cross-functional collaboration to maintain high standards across systems and processes, while navigating a fast-paced, regulated setting.

Qualifications

• B.Sc. degree in a scientific discipline or related field (preferably Electronics).
• Minimum 3 years as a Quality Engineer in a multinational medical device environment.
• Experience with qualification/validation of test methods and processes.
• Strong knowledge of Six Sigma, statistics, sampling, risk assessment, and RCA.
• Six Sigma certification is a plus.
• Experience planning product validation studies in pharma/medical devices.
• Familiarity with FDA QSR, ISO 13485, and MDR regulations.
• Excellent English communication, written and spoken.
• Strong organizational and analytical skills with attention to detail.
• Ability to manage multiple projects with cross-functional interfaces.

Responsibilities

• Lead validation programs and risk management activities across operations.
• Support audits and ensure regulatory compliance.
• Collaborate with internal and external teams to ensure high standards.
• Maintain risk management documentation and validation records.
• Drive continuous improvement in validation processes.

Skills

English communication

Analytical thinking

Organizational skills

Cross-functional collaboration

Problem-solving

Travel willingness

Education

B.Sc./B.E. in Engineering or related field

Tools

Six Sigma

Statistical analysis

Risk assessment

Root cause analysis

Job description

Novocure Inc. seeks a Process Validation Engineer to join the Operations Engineering team in a hybrid role from Cracow. You will lead validation and risk activities to ensure quality and regulatory compliance in a global medical device environment.

You will manage validation programs, risk documentation, audits, and cross-functional collaboration to maintain high standards across systems and processes, while navigating a fast-paced, regulated setting.