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 at DivIHN Integration Inc. will play a pivotal role in the design, development, and integration of complex systems, with a focus on adhering to INCOSE principles and the EU MDR requirements. This remote position requires a thorough understanding of system engineering processes, along with a strong analytical mindset to ensure that all technical specifications align with project deliverables. The role demands collaboration with cross-functional teams, effective communication skills, and a keen eye for detail to maintain compliance with regulatory standards while delivering innovative engineering solutions.

Job Responsibilities

• Develop and implement system engineering processes consistent with INCOSE standards.
• Ensure compliance with EU Medical Device Regulations throughout the project lifecycle.
• Conduct system architecture analysis, risk analysis, and requirements management.
• Collaborate with product managers, stakeholders, and development teams to define system requirements.
• Facilitate design reviews and verification activities to ensure specifications are met.
• Implement strategies for system integration and validation, managing any associated issues.
• Support the documentation of system configurations and engineering changes.
• Maintain up-to-date knowledge of relevant technologies and regulatory guidelines relevant to the medical device industry.

Qualifications

• Bachelor's degree in Systems Engineering, Computer Science, Electrical Engineering, or a related field.
• Minimum of 5 years of experience in systems engineering within the medical device sector.
• Strong understanding of INCOSE principles and EU MDR requirements.
• Proven experience in system architecture, verification, and validation processes.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to communicate complex technical concepts clearly to diverse audiences.
• Familiarity with tools and methodologies used in systems engineering and compliance documentation.

Technologies & Tools

The Systems Engineer will utilize various software tools and technologies to manage engineering processes effectively. These include requirements management tools such as DOORS, project management software like JIRA or Trello, simulation and modeling tools like MATLAB or Simulink, and documentation platforms for compliance purposes such as eQMS or Microsoft Office Suite. Familiarity with programming languages such as Python or C++ may also be beneficial for automation and data analysis tasks.

Ideal Candidates

The ideal candidate for this position will possess a proactive, detail-oriented, and adaptive mindset, capable of thriving within fast-paced environments. Strong interpersonal skills along with the ability to work collaboratively with diverse teams are crucial. Successful candidates will demonstrate a commitment to continuous learning, a passion for system engineering, and a drive to ensure regulatory compliance while fostering innovation in medical device technology.