Safety Engineer

Senior Safety Engineer

My cleint is Medical Tech company founded with the clear goal, to bring a more human way to treat cancer. As a Senior Safety Engineer you will join a team developing a patient positioning system and treatment delivery system.

Relevant knowledge and skills required:

This is an individual contributor role leading and owning the risk management file:

• A Bachelor's or Master's degree in engineering or other bachelor's degree with relevant experience will also be considered
• Previous experience with medical devices is highly desirable
• Good understanding of the product development life cycle
• Use of lifecycle management tools such as ALM, Jira, CodeBeamer
• To lead the product risk management board of subject matter experts from various domains (Engineering, Product Management, and Clinical Representatives)
• Responsible for the risk file and proper maintenance of the respective design documentation throughout the lifetime of the assigned products
• Represent the team in safety aspects of the product
• Challenging the design and conceptional decisions affecting the safety of the product
• Familiar with the general standards of our medical products and can translate those regulations into real-life implementations
• Comply with local and global Quality Assurance Procedures. Informed about basic standards applicable to our products
• Organize and/or participate in risk assessments of the product (design FMEA, Risk Management Reports, critical list of components…etc)
• Assess Complaints from the field and Discrepancy Reports for potentially new hazards.
• Ensure proper handling and compliance of the risk related documentation together with Regulatory and Quality Affairs
• Represent the risk aspects of the product to internal and external auditors
• Monitor and present risk related topics
• Ability to connect effectively in person and remotely through verbal and written presentations
• Ability to work on assigned tasks under time constraints independently
• Experience working with a cross-functional team of technical and clinical people

Key Responsibilities

• Experienced in basic Risk Assessment processes/protocols and/or a track record
• Focus of position is technical, but good understanding of regulatory aspects is expected.
• Professional work experience in the Medical Devices Industry
• Personality with high analytical and conceptual thinking and excellent interpersonal skills

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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