Senior Designer - MDR, 510(k), DHF Remediation
India
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Job Description
Senior Designer - MDR, 510(k), DHF Remediation

Job Summary

The Senior Designer - MDR plays a pivotal role in creating high-quality designs that align with the overall project vision and meet customer requirements. This role focuses on leveraging extensive knowledge in Medical Device Regulations (MDR) to ensure designs are compliant, innovative, and effective. The designer will collaborate with various stakeholders, mentor junior team members, and validate design concepts through practical implementations, significantly impacting the organization's success in delivering exceptional products.

Key Responsibilities

1. Collaborate With Stakeholders To Gather And Refine Design Requirements, Ensuring Alignment With Mdr Compliance Standards And Customer Expectations.
2. Develop Prototypes And Proof-Of-Concept Implementations Using Design Tools And Methodologies To Validate Design Decisions And Facilitate Feedback.
3. Mentor Junior Designers By Sharing Knowledge And Expertise Through Structured Training Sessions And Comprehensive Documentation, Fostering Skill Development Within The Team.
4. Work With Cross-Functional Teams To Ensure Software Design Aligns With Overall Project Goals And Adheres To Mdr Guidelines.
5. Collaborate With Quality Assurance Teams To Establish And Uphold High-Quality Design Processes And Methodologies That Ensure Regulatory Compliance.

Skill Requirements

1. Strong Understanding Of Medical Device Regulations (Mdr) And Related Compliance Standards.
2. Proficiency In Design Tools And Methodologies, With Experience In Creating Prototypes And Proof-Of-Concept Implementations.
3. Familiarity With Stakeholder Engagement And Requirement Gathering Techniques.
4. Solid Knowledge Of Quality Assurance Processes And Practices In Design.

Other Requirements

1. Optional But Valuable: Certification In Iso 13485 Or Relevant Medical Device Design Certifications.
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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 220,000 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 2024 totaled $13.8 billion.
23 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: https://rmkcdn.successfactors.com/147eb21f/a701dca9-f32d-4fc9-9447-6.svg Industry-benchmarked compensation https://rmkcdn.successfactors.com/147eb21f/b0c54381-ddcc-4a33-9b35-9.svg Best-in-class healthcare benefits https://rmkcdn.successfactors.com/147eb21f/b73027be-7aae-4d36-a090-4.svg Personal time off https://rmkcdn.successfactors.com/147eb21f/d5b4fdfd-2e99-4e26-9878-9.svg Maternity and paternity benefits https://rmkcdn.successfactors.com/147eb21f/3d42b0fc-4652-435a-9ece-c.svg Access to skills / higher education programs/resources https://rmkcdn.successfactors.com/147eb21f/aeddeaf2-9e25-4584-ad11-d.svg Discounts on products and services via Benefit Box https://rmkcdn.successfactors.com/147eb21f/a9609a3b-2700-4b3c-9d90-a.svg Participate in CSR programs and live life with a purpose https://rmkcdn.successfactors.com/147eb21f/c6e33851-710f-4634-bd69-f.svg 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.