Developer MDR, PFMEA

HCL Technologies

HCL Technologies

Software Engineering

Posted on May 29, 2026
Job Description
Developer MDR, PFMEA
Others, Distrito Capital de Bogotá

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.
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 226,300 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending December 2025 totaled $14.5 billion.

Benefits

At HCLTech, we believe in empowering our employees with comprehensive benefits that support their professional growth and enhance their well-being. When you sign up for a career with us, you gain access to:

Industry-benchmarked compensation

Best-in-class healthcare benefits

Personal time off

Maternity and paternity benefits

Access to skills / higher education programs/resources

Discounts on products and services via Benefit Box

Participate in CSR programs and live life with a purpose

Opportunities to grow and advance your career

Note: The benefits listed above vary depending on the nature of your employment and the country where you work. Some benefits may be available in some countries but not in all.