Developer MDR, PFMEA

Job Summary

The Developer will be responsible for mdr, medical iso13485 process, and Process Failure Mode Effect Analysis (PFMEA). They will play a crucial role in ensuring compliance with ISO 13485 standards and improving the efficiency and reliability of medical devices through PFMEA.

Key Responsibilities

1. Develop and maintain software applications related to mdr requirements and medical device regulations.

2. Implement and adhere to iso 13485 standards in the development process.

3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate potential risks in the development process.

4. Collaborate within team to ensure alignment with regulatory requirements and quality standards.

5. Participate in the design and implementation of solutions to enhance the safety and effectiveness of medical devices.

6. Support continuous improvement initiatives to optimize processes and workflows.

Skill Requirements

1. Understanding of mdr regulations and medical device directives.

2. Knowledge of implementing iso 13485 standards in software development processes.

3. Familiarity with conducting process failure mode effect analysis (pfmea) in a medical device development context.

4. Analytical and problem-solving skills to identify and address risks effectively.

5. Good communication skills to collaborate with internal teams and external stakeholders.

6. Attention to detail and ability to work in a regulated environment.

7. Knowledge of quality management systems in the healthcare industry.

Other Requirements

1.Relevant certifications in mdr, ISO 13485, or PFMEA processes would be advantageous.