HCL Technologies
Senior Designer – MDR
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
Collaborate with stakeholders to gather and refine design requirements, ensuring alignment with MDR compliance standards and customer expectations.
Develop prototypes and proof‑of‑concept implementations using design tools and methodologies to validate design decisions and facilitate feedback.
Mentor junior designers by sharing knowledge and expertise through structured training sessions and comprehensive documentation, fostering skill development within the team.
Work with cross‑functional teams to ensure software design aligns with overall project goals and adheres to MDR guidelines.
Collaborate with quality assurance teams to establish and uphold high‑quality design processes and methodologies that ensure regulatory compliance.
Skill Requirements
Strong understanding of Medical Device Regulations (MDR) and related compliance standards.
Proficiency in design tools and methodologies, with experience in creating prototypes and proof‑of‑concept implementations.
Familiarity with stakeholder engagement and requirement gathering techniques.
Solid knowledge of quality assurance processes and practices in design.
Certification
Optional but valuable: Certification in ISO 13485 or relevant medical device design certifications.
Location Santa Clara, California
Pay Range Minimum: $68,000; Maximum: $105,000
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Key Responsibilities
Collaborate with stakeholders to gather and refine design requirements, ensuring alignment with MDR compliance standards and customer expectations.
Develop prototypes and proof‑of‑concept implementations using design tools and methodologies to validate design decisions and facilitate feedback.
Mentor junior designers by sharing knowledge and expertise through structured training sessions and comprehensive documentation, fostering skill development within the team.
Work with cross‑functional teams to ensure software design aligns with overall project goals and adheres to MDR guidelines.
Collaborate with quality assurance teams to establish and uphold high‑quality design processes and methodologies that ensure regulatory compliance.
Skill Requirements
Strong understanding of Medical Device Regulations (MDR) and related compliance standards.
Proficiency in design tools and methodologies, with experience in creating prototypes and proof‑of‑concept implementations.
Familiarity with stakeholder engagement and requirement gathering techniques.
Solid knowledge of quality assurance processes and practices in design.
Certification
Optional but valuable: Certification in ISO 13485 or relevant medical device design certifications.
Location Santa Clara, California
Pay Range Minimum: $68,000; Maximum: $105,000
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