Senior Design Lead - MDR, 510(k), DHF Remediation
United States
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Job Description
Senior Design Lead - MDR, 510(k), DHF Remediation
Palm Beach, Florida

Job Summary

The Senior Design Lead is pivotal in shaping and overseeing the design direction for multiple projects within the Medical Device Regulations (MDR) landscape. This role emphasizes the importance of user-centric design while ensuring adherence to regulatory standards. The Senior Design Lead will drive innovation, set organizational design standards, and foster collaboration within design teams to achieve strategic business objectives.

Key Responsibilities

1. Leverage Design Expertise In Mdr To Create User-Friendly And Intuitive Software And Products That Comply With Regulatory Requirements, Contributing To Seamless User Experiences And Enhancing Customer Satisfaction.
2. Lead And Mentor A Team Of Designers, Providing Guidance On Best Practices In Design Methodologies And Ensuring The Delivery Of High-Quality Design Solutions That Align With Business Goals And Regulatory Standards.
3. Present Design Concepts Effectively To Stakeholders, Playing A Crucial Role In Shaping The Design Vision And Strategy While Ensuring Alignment With Mdr Compliance And Organizational Objectives.
4. Stay Abreast Of Industry Trends, Emerging Technologies, And Regulatory Changes, Driving Innovation And Excellence In Design Practices Within The Mdr Framework.
5. Collaborate With Cross-Functional Teams, Including Engineering And Compliance, To Ensure That Design Processes Are Integrated With Product Development And Adhere To Iso 13485 Standards.
6. Conduct User Research And Usability Testing To Gather Insights That Inform Design Decisions And Validate Design Solutions Against User And Regulatory Expectations.

Skill Requirements

1. Advanced Proficiency In Mdr Standards And Processes, With A Strong Understanding Of Regulatory Requirements Related To Medical Device Design.
2. Solid Experience In User-Centered Design Principles, Usability Testing, And Design Thinking Methodologies.
3. Excellent Skills In Design Tools And Technologies, Such As Sketch, Adobe Creative Suite, Or Figma.
4. Strong Understanding Of Iso 13485 And Its Impact On The Design Process In Medical Devices.
5. In-Depth Knowledge Of Emerging Technologies And Design Trends Relevant To The Healthcare Sector.

Other Requirements

1. Certification In Human Factors Engineering (Hfes) Or Design For Medical Devices Is Optional But Valuable.
2. Relevant Certifications In Iso Standards Or Medical Device Design Processes Are Highly Recommended.
Maximum Salary (US):  122000
Minimum Salary (US):  80000
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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 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.

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.