Systems Engineer (EU MDR)- Remote

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Written by AI from the job title and company, not by DivIHN Integration Inc, so some details may not match this job. The employer's own page has the real description.

Job Overview

DivIHN Integration Inc. is seeking a skilled Systems Engineer (EU MDR) to join our team in a remote capacity. The successful candidate will be responsible for ensuring compliance with the European Medical Device Regulation (EU MDR) standards, facilitating the design, development, implementation, and maintenance of systems that support the regulatory requirements for medical devices. This role requires a proactive approach in managing compliance-related activities, enhancing systems architecture, and collaborating with cross-functional teams to ensure that our products meet the highest standards of safety and efficacy.

Job Responsibilities

• Develop and implement system-level solutions that conform to EU MDR regulations.
• Review and analyze technical documentation to ensure compliance with regulatory requirements.
• Collaborate with product development teams to integrate regulatory standards into the design process.
• Conduct risk assessments and prepare necessary documentation to support compliance submissions.
• Facilitate training and awareness sessions on EU MDR standards among project teams.
• Monitor and assess changes in regulations, updating systems and processes accordingly.
• Assist in audits and inspections related to quality compliance.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• Minimum of 3 years of experience in a Systems Engineering role with a focus on medical devices.
• In-depth understanding of EU MDR regulations and compliance processes.
• Strong experience in risk management and assessment methodologies.
• Proficiency in project management tools and software.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a remote team environment.

Technologies & Tools

The Systems Engineer will utilize a variety of technologies and tools to ensure systems compliance and efficacy. Key technologies include compliance management software, risk management tools, and project management applications. Familiarity with document control systems and data analysis tools will be critical in monitoring system performance and regulatory adherence.

Ideal Candidates

Ideal candidates for this position will possess a strong analytical mindset, attention to detail, and a proactive approach to problem-solving. They should demonstrate effective communication skills and an ability to navigate complex regulatory landscapes. Candidates who thrive in collaborative environments and exhibit adaptability to changing regulations and technologies will excel in this role. A passion for enhancing product safety and compliance in medical devices is essential.