Systems Engineer (INCOSE/EU MDR) - Remote

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

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.

DivIHN Integration Inc. is seeking a skilled Systems Engineer with expertise in INCOSE practices and EU MDR regulations to join our dynamic team in a remote capacity. The ideal candidate will be responsible for leading system-level engineering processes, ensuring regulatory compliance, and facilitating cross-functional collaboration in the development and maintenance of cutting-edge systems. This role requires a deep understanding of systems engineering principles, excellent problem-solving abilities, and the capacity to communicate complex technical information effectively. You will play a key role in ensuring that our systems meet the highest standards of quality and reliability while aligning with organizational objectives.

Job Responsibilities

• Develop and implement systems engineering processes in accordance with INCOSE and EU MDR standards.
• Collaborate with cross-functional teams to define system requirements and ensure compliance with regulatory frameworks.
• Conduct risk assessments and impact analyses to identify potential challenges and develop mitigation strategies.
• Create and manage system-level documentation, including requirements specifications, design documents, and validation protocols.
• Lead system testing and validation activities, ensuring all systems operate within defined parameters.
• Provide technical guidance and support throughout the product lifecycle, from concept through delivery and beyond.
• Participate in continuous improvement initiatives to enhance efficiency and effectiveness of engineering processes.

Qualifications

• Bachelor’s degree in Systems Engineering, Computer Science, or related field; Master's degree preferred.
• At least 5 years of experience in systems engineering, with a focus on medical device development or similar domains.
• Strong understanding of INCOSE guidelines and EU MDR regulations.
• Proficiency in requirements management and systems design tools.
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills, with the ability to present complex information clearly.
• Experience with risk management methodologies and tools.

Technologies & Tools

The Systems Engineer will primarily utilize a range of technologies and software tools to enhance project management and systems engineering processes. These include requirements management tools such as DOORS or Jama Connect, modeling software like MATLAB and Simulink, and various project management platforms to coordinate team efforts effectively. Familiarity with simulation and testing frameworks, along with prototyping tools, will also be advantageous.

Ideal Candidates

The ideal candidates for this position will possess a blend of technical expertise and interpersonal skills. Successful candidates should demonstrate a proactive attitude, a strong commitment to regulatory excellence, and the ability to thrive in a collaborative environment. They will have a keen attention to detail and a passion for continuous learning and innovation. Individuals who can adapt to evolving project requirements and who excel in complex problem-solving scenarios will find themselves well-suited for this role.