Senior Developer

Skill (Primary)

Technical Skills (ERS)-SAP PLM - Configuration-Process Failure Mode Effect Analy(PFMEA)

Location

Gurugram

Job Family

Development

Job Description (Posting).

About HCLTech
HCLTech is a global technology company, spread 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. We re powered by our people a global, diverse, multi-generational talent - representing 161 nationalities whose unique spark, perspective and boundless passion drive our culture of proactive value creation and problem-solving.
Our purpose is to bring together the best of technology and our people to supercharge progress for everyone, everywhere our clients, partners, their stakeholders, communities, and the planet. As a company, we are deeply focused on accelerating our ESG agenda. We are also creating technology-enabled sustainable solutions with and for our clients and partners. We embed ESG imperatives into every aspect of our business and ensure that the progress we supercharge is responsible, inclusive and beneficial to all our stakeholders in the long term. We have committed to achieving net zero by 2040.

To learn more about how we can supercharge progress for you, visit www.hcltech.com

Senior Developer with mdr,medical - iso13485 process,Process Failure Mode Effect Analy(PFMEA)

Job Summary
The Senior Developer will be responsible for mdr,medical iso13485 process and Process Failure Mode Effect Analysis (PFMEA). The primary objective is to develop and implement software solutions in compliance with medical device regulations and quality standards. (1.) Key Responsibilities
1. Develop and maintain software applications in adherence to mdr,medical iso13485 process requirements
2. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in software development processes
3. Collaborate within team to ensure software solutions meet regulatory standards and quality expectations
4. Participate in audits and reviews to assess software development processes for compliance with industry regulations
5. Provide technical expertise and guidance on mdr,medical iso13485 process and pfmea best practices

Skill Requirements
1. Proficiency in mdr,medical iso13485 process and quality management systems
2. Experience in conducting process failure mode effect analysis (pfmea) in software development projects
3. Strong knowledge of medical device regulations and standards
4. Good problem-solving skills and attention to detail
5. Ability to work effectively in a team environment and communicate complex technical concepts clearly
6. Familiarity with software development lifecycle and best practices

Certifications: Certification in mdr,medical iso13485 process or PFMEA is a plus

Skill Level 3 (Secondary Skill 1)

Tools and Standards (ERS)-Standards - Medical-MDR

Skill Level 3 (Secondary Skill 2)

Tools and Standards (ERS)-HW Product Dev Process Standard-Medical - ISO13485 Process

Experience Level

Senior Level