Risk and Validation Engineer

Novocure Inc.; Poland; On-site; 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

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Permanent contract of employment, hybrid working model from Cracow office – Fabryczna Office Park.(3 days from office, 2 days from home)

JOB SUMMARY:

We are looking for aProcess Validation Engineerto join our Operations Engineering team and play a key role in ensuring the quality, compliance, and reliability of our manufacturing processes and equipment within a global medical device environment.

In this role, you will lead and support validation and risk management activities across internal and external operations, helping ensure compliance with FDA and ISO requirements while driving continuous improvement initiatives.
You will be responsible for managing validation programs, maintaining risk management documentation, supporting audits, and collaborating closely with cross-functional teams to ensure high standards across systems, products, and processes.

This position requires a strong combination of technical expertise, analytical thinking, organizational skills, and the ability to manage multiple priorities in a fast-paced and highly regulated environment.

Success in this role means becoming a trusted subject matter expert for validation and risk-related activities, driving projects forward with a high level of ownership, maintaining strong collaboration with internal and external stakeholders, and ensuring compliance and operational excellence across validation processes.

What you will bring:

• B.Sc. degree in a scientific discipline or related Engineering/Science field, preferably Electronics,, or equivalent practical engineering qualification in a relevant field
• Minimum of 3 years of experience as a Quality Engineer in a multinational medical device manufacturing and distribution environment
• Experience with qualification and validation of test methods, manufacturing processes, and related equipment used in validation, verification, or manufacturing activities
• Strong knowledge and practical use of quality tools such as Six Sigma, statistical techniques, sampling principles, risk assessment, and root cause analysis
• Six Sigma certification – an advantage
• Experience planning and overseeing product validation studies within the pharma and/or medical device industry
• Working knowledge of FDA medical device Quality Systems Regulations and strong understanding of quality regulations and standards, including 21 CFR 820, ISO 13485, and MDR
• Understanding of electro-medical devices and relevant regulations – an advantage
• Excellent English communication skills, both written and verbal
• Strong organizational and analytical skills with close attention to detail
• Ability to manage multiple projects and priorities simultaneously while interfacing effectively across all organizational levels

Who you are:

• Committed, patient-oriented, and quality-driven
• Detail-oriented with a strong analytical mindset and problem-solving approach
• Flexible and adaptable in dynamic environments with changing priorities
• Able to work independently while also being a collaborative team player
• Skilled at building strong and positive working relationships across cross-functional teams
• Comfortable working within tight and unpredictable timelines
• Willing and able to travel abroad from time to time

ABOUT US:

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you'll connect, grow, and make a real difference. We're a company with the drive of a startup and the strength that comes with 25 years of success.

Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.

This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.

COMPENSATION :

The annual base salary ranges from192 000 PLN to 204 000 PLN yearly*.

This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated.

BENEFITS:

• Life Insurance
• Performance Bonus
• Private Medical Care
• ...and more!

Novoflex – our trust-based hybrid work philosophy

We offer a flexible, trust-based hybrid working model for our office-based roles. Employees are asked to be in the office an average of three days per week, with the flexibility to choose which days work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early, starting late, or working fewer days occasionally, we trust you to balance your time in a way that works for both you and Novocure.