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.

Overview

DivIHN Integration Inc. is seeking a dedicated and detail-oriented Systems Engineer with expertise in INCOSE and EU MDR to join our remote team. The ideal candidate will play a pivotal role in ensuring compliance with engineering standards and regulations. They will be responsible for the comprehensive engineering of systems, leading projects through lifecycle development, and collaborating with cross-functional teams to deliver effective solutions that meet stakeholder needs. The Systems Engineer will also be instrumental in fostering an environment of continuous improvement and innovation within our engineering practices.

Job Responsibilities

• Develop and implement systems engineering processes in accordance with INCOSE guidelines and EU MDR regulations.
• Collaborate with multidisciplinary teams to define system requirements and ensure compliance with regulatory standards.
• Conduct risk assessments and establish mitigation strategies to enhance system reliability and performance.
• Lead peer reviews of requirements, design, and verification documents to ensure quality deliverables.
• Manage the entire system lifecycle including planning, development, verification, and validation phases.
• Provide technical support to project teams in matters related to systems engineering and compliance.
• Maintain documentation of processes and results, ensuring consistency and traceability.
• Participate in training sessions, ensuring team members stay updated on regulatory changes and best practices in systems engineering.

Qualifications

• Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, or a related field; a Master’s degree is preferred.
• 3+ years of experience in a systems engineering role, with proven expertise in INCOSE methodologies and EU MDR compliance.
• Certification in Systems Engineering (CSEP, ESEP, or equivalent) is highly desirable.
• Strong understanding of engineering standards, regulations, and best practices.
• Proficiency in systems modeling tools and methodologies.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to work collaboratively with diverse teams.

Technologies & Tools

The Systems Engineer will utilize a variety of technologies and tools to support system development and compliance. Key tools may include Systems Modeling Language (SysML), Requirements Management tools (such as DOORS or Jama Connect), simulation and modeling software (such as MATLAB or Simulink), and project management tools (such as Jira or Trello). Familiarity with regulatory compliance software and documentation tools is also essential to ensure adherence to EU MDR guidelines.

Ideal Candidates

The ideal candidate for this Systems Engineer position will possess a strong analytical mindset, coupled with the ability to think creatively and strategically about engineering challenges. They should demonstrate a commitment to quality and possess excellent organizational skills, enabling them to manage multiple projects effectively. Ideal candidates will also be proactive in identifying areas for improvement and innovative solutions, with a collaborative spirit that thrives in a remote team environment. Strong communication skills are critical, as the role involves liaising with diverse stakeholders to achieve project objectives.