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

The Systems Engineer (EU MDR) at DivIHN Integration Inc. is responsible for ensuring that medical devices comply with the European Union Medical Device Regulation (EU MDR). This position involves collaborating with cross-functional teams to develop and implement systems engineering solutions that facilitate regulatory compliance throughout the product lifecycle. The successful candidate will be adept at analyzing product specifications, ensuring quality assurance, and maintaining adherence to both internal and external standards while effectively managing project timelines and deliverables.

Job Responsibilities

• Conduct comprehensive studies and analyses to ensure compliance with EU MDR requirements.
• Develop and implement systems engineering processes for medical device qualification.
• Coordinate with regulatory affairs to prepare necessary documentation for device submissions.
• Perform risk assessments and utilize risk management methodologies aligned with EU MDR.
• Collaborate with product development teams to ensure design controls are effectively applied.
• Prepare technical reports and presentations for stakeholders and regulatory bodies.
• Monitor project timelines and milestones to ensure timely delivery of compliance objectives.
• Continuous improvement of processes to enhance regulatory compliance workflows.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.
• Minimum of 3 years of experience in systems engineering, particularly in medical devices.
• In-depth knowledge of EU MDR and related regulatory requirements.
• Proficient in risk management and quality assurance methodologies.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication abilities.
• Experience working in a remote or flexible work environment.

Technologies & Tools

This position requires proficiency in various technologies and tools essential for compliance and engineering tasks, including but not limited to:

• Regulatory compliance software such as MasterControl or Veeva Vault.
• Project management tools like Jira or Trello.
• Risk management tools such as RiskWatch or FMEA software.
• Data analysis tools including MATLAB or Excel.

Ideal Candidates

Ideal candidates for the Systems Engineer (EU MDR) position will be those who exhibit exceptional attention to detail and a passion for regulatory compliance within the medical device industry. They should possess strong teamwork capabilities, demonstrating flexibility and adaptability in a remote working environment. Possessing excellent time-management skills and the ability to navigate complex situations with a solutions-oriented mindset will also be critical for success in this role. Moreover, candidates will be expected to maintain a high level of professionalism and integrity while effectively communicating with diverse teams and stakeholders.