Systems Engineer

Normandy Hadrontherapy; Caen; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Normandy Hadrontherapy is seeking a validation professional to specify, develop, and validate the system, subsystems, and components, ensuring data integrity in the ERP reflects the product and requirements flow-down.

You will define the validation strategy, write clear test procedures, and validate analyses and reports. The role includes training engineers, coordinating outsourcing, and ensuring compliance with regulatory requirements.

Qualifications

• Master’s degree or engineering degree in electrical or electronic engineering.

Responsibilities

• Establish a validation test strategy and develop and maintain validation test plans.
• Maintain and validate the test strategy.
• Ensure validation plans are approved.
• Supervise and train engineers in the field.
• Develop and maintain training materials.
• Deliver training sessions and record training videos.
• Manage the outsourcing of components to another department or to subcontractors.
• Recommend or decide whether to manufacture components in-house or purchase them.
• Qualify and select potential component suppliers for purchasing.
• Prepare technical sections of requests for proposals (RFPs).
• Monitor and manage the technical aspects of subcontractor activities.
• Prepare and maintain requests for proposals or internal contracts.
• Monitor technological and scientific developments.
• Research and share publications, attend conferences, identify research topics, and participate in international working groups.
• Train, support the development of, and coach team members as the team is established.
• Ensure team members receive appropriate training and that proposed improvements are implemented.

Skills

Electrical engineering

Analytical thinking

Communication skills

Presentation skills

Teamwork

Education

Master’s degree or engineering degree in electrical or electronic engineering

Job description

They are responsible for specifying, developing, and validating the system, subsystems, and/or critical components, ensuring that the data recorded in the ERP system accurately reflects the product.

In collaboration with the Risk and Specifications Department, they define the strategy for the equipment and its subsystems.

1 Description of Activities

Gather, analyze, challenge, and negotiate high-level requirements.

Reach a consensus on received requirements.

Analyze and mitigate risks through risk analysis and Failure Mode, Effects, and Criticality Analysis (FMECA).

Validate risk analyses and/or FMECA reports.

Define the system breakdown into subsystems and/or components, and describe their requirements flow-down.

Produce a validated system description and verify vertical traceability.

Write requirements in clear, concise, unambiguous, plain language, following the SMART criteria. This includes regulatory requirements.

Draft test procedures and verify test coverage.

Validate and maintain test procedures.

Validate the horizontal traceability matrix.

Test and validate components in accordance with test procedures and the test plan.

Prepare validation test reports.

Develop technical solutions.

Conduct simulations, build prototypes, and perform feasibility studies.

Develop and maintain the test environment.

2 Associated Responsibilities and Level of Autonomy

Establish a validation test strategy and develop and maintain validation test plans.

Maintain and validate the test strategy.

Ensure validation plans are approved.

Supervise and train engineers in the field.

Develop and maintain training materials.

Deliver training sessions and record training videos.

Manage the outsourcing of components to another department or to subcontractors.

Recommend or decide whether to manufacture components in-house or purchase them (make-or-buy decisions).

Qualify and select potential component suppliers for purchasing.

Prepare technical sections of requests for proposals (RFPs).

Monitor and manage the technical aspects of subcontractor activities.

Prepare and maintain requests for proposals or internal contracts.

Monitor technological and scientific developments.

Research and share publications, attend conferences, identify research topics, and participate in international working groups.

Train, support the development of, and coach team members as the team is established.

Ensure team members receive appropriate training and that proposed improvements are implemented.

3 Internal / External Working Relationships

Reports to the Head of the Experts Group.

Works with NHa’s internal departments directly involved in the project(s), including Experts, Engineering, Production and Installation, Clinical and Treatment Affairs, Purchasing and Logistics, Quality and Regulatory Affairs, and Health, Safety and Environment (HSE).

Works with suppliers and subcontractors.

4 Specific Professional Knowledge

Master’s degree or engineering degree in electrical or electronic engineering (minimum requirement).

Excellent theoretical and practical knowledge of electrical engineering and electronics.

Good theoretical and practical knowledge of physics and mechanics.

Excellent verbal and written communication skills.

Excellent presentation and reporting skills.

Strong analytical and problem-solving skills.

Excellent research and data collection skills.

Proactive mindset and ability to work as part of a team.