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

DivIHN Integration Inc. is seeking a dedicated and skilled Systems Engineer (EU MDR) to join our dynamic team in a remote capacity. The ideal candidate will play a crucial role in ensuring that our medical devices meet the European Union Medical Device Regulation (EU MDR) requirements. This position will involve collaborating with cross-functional teams to develop, implement, and maintain compliance strategies that align with regulatory standards, ultimately ensuring product quality and safety in the market.

Job Responsibilities

• Develop and implement systems engineering processes to fulfill EU MDR requirements.
• Conduct risk assessments and engage in risk management strategies for medical device compliance.
• Collaborate with product development teams to ensure all products meet design control requirements.
• Prepare and maintain all documentation to support regulatory submissions and audits.
• Lead cross-functional teams in creating and reviewing validation and verification protocols.
• Provide training and support for teams regarding EU MDR compliance practices.
• Stay updated on regulatory changes and provide guidance on impact to existing products.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in systems engineering, preferably in the medical device industry.
• In-depth knowledge of EU MDR and related regulatory standards.
• Experience in risk management and quality assurance practices.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficient in technical writing and documentation.

Technologies & Tools

The Systems Engineer will be expected to utilize various technologies and tools throughout their daily tasks. This includes familiarity with systems engineering software, regulatory compliance management tools, project management applications, and design control platforms that facilitate collaboration and documentation management within cross-functional teams.

Ideal Candidates

The ideal candidate for the Systems Engineer (EU MDR) position is someone who possesses a proactive attitude and an eye for detail. They should exhibit strong organizational skills and the ability to manage multiple projects simultaneously. Additionally, an effective communicator who is comfortable in a collaborative, remote work environment will thrive in this role. A genuine passion for improving patients' lives through high-quality medical devices will also align well with our company’s mission.