Systems Engineer (INCOSE/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

The Systems Engineer (INCOSE/EU MDR) at DivIHN Integration Inc. plays a pivotal role in ensuring the integrity and functionality of complex systems within our projects. This remote position will involve collaborating with multidisciplinary teams to develop, implement, and review system engineering practices, with a strong emphasis on compliance with international standards. The candidate will be responsible for identifying system requirements, performing system verification and validation, and managing technical documentation, all while fostering effective communication among stakeholders to achieve project objectives in a timely manner.

Job Responsibilities

• Conduct system-level engineering analysis and design for complex systems in adherence to INCOSE and EU MDR guidelines.
• Develop and maintain detailed documentation including requirements specifications, design documents, and verification plans.
• Implement system verification and validation protocols to ensure compliance with applicable standards.
• Collaborate with cross-functional teams to assess system performance and integrate new technologies and processes.
• Identify and mitigate technical risks throughout the project lifecycle.
• Provide expert consultation to stakeholders regarding system design and implementation strategies.
• Oversee project timelines and deliverables, ensuring milestones are met within budget constraints.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field; a Master’s degree is preferred.
• Minimum of 5 years of professional experience in systems engineering or a related discipline.
• Proven experience with INCOSE standards and EU Medical Device Regulations (MDR).
• Strong analytical and problem-solving skills, with the ability to work independently.
• Proficiency in system modeling tools and methodologies.
• Exceptional written and verbal communication skills with an ability to present complex information clearly.
• Experience with project management tools and methodologies is advantageous.

Technologies & Tools

The Systems Engineer will utilize a variety of technologies and tools, including system modeling software such as Cameo Systems Modeler or MagicDraw, requirements management tools like DOORS or Jama Connect, and simulation tools. Proficiency in programming languages such as Python or MATLAB may also be required for specific tasks. Familiarity with project management software such as Microsoft Project or JIRA will be beneficial for tracking project milestones and communication.

Ideal Candidates

The ideal candidates for the Systems Engineer (INCOSE/EU MDR) position possess a deep understanding of systems engineering principles and exhibit a high level of professionalism. They are detail-oriented, capable of multi-tasking, and demonstrate a commitment to quality and compliance. Strong interpersonal skills for effective collaboration in a remote setting are essential, as well as the ability to quickly adapt to changing project requirements. A proactive attitude towards problem-solving and a passion for continuous learning will also make candidates stand out.