Design Transfer SME Design Controls Remediation
Intellectt INC
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Job Details
Skills
- Process Validation
- Design Control
- 21CFR
- ISO Standards
- Design Transfer
- DMR
Summary
Role: Design Transfer SME Design Controls Remediation (Medical Device)
Duration: 12 Months
Location: Remote
Client : Medical Device
Job Summary
We are seeking a Design Transfer SME with strong medical device experience to support design transfer gap assessments and remediation activities. This role ensures smooth transition of product designs into manufacturing while maintaining compliance with design control requirements.
Key Responsibilities:
- Review and identify gaps in design transfer plans and manufacturing documentation.
- Support development and updates of Process Validations (IQ/OQ/PQ), Test Method Validations (TMV), Software Validations.
- Review and update Device Master Records (DMR) as needed.
- Ensure design transfer activities align with (V&V),Production processes,Supplier controls,Risk management requiments
- Work with cross-functional teams (Design, Manufacturing, Quality).
- Maintain traceability between Design Inputs, Outputs, and transfer documentation.
Required Qualifications :
- Bachelor's degree in Engineering or related field.
- Experience with medical device design transfer and process validation.
- Strong knowledge of ISO 13485 and 21 CFR 820 design control requirements.
- Experience supporting manufacturing process development and validation.
- Experience performing design transfer gap assessments or remediation.
- Strong documentation and coordination skills.
- Dice Id: 91111992
- Position Id: 2026-37646
- Posted 30+ days ago
Company Info
Intellectt Inc. is a global IT and next-generation engineering solutions company
that helps graded enterprises innovate, scale, and stay competitive in a digital-first world. We
combine deep domain expertise with advanced engineering, digital, and manufacturing
capabilities to solve complex challenges across industries such as Healthcare, BFSI, Aerospace,
Automotive, Manufacturing, Telecom, Retail, and Energy. With a team of 2,500+ professionals, including 1,800+ engineers, and 15 global delivery centers across the USA, India, Canada, Mexico, Ireland, and Asia, Intellectt delivers high-quality, scalable solutions. The company has achieved an annual revenue of $270 million, reflecting strong growth and client trust. Our core capabilities include Engineering & Manufacturing, Validation & Quality, Digital Technologies, Healthcare Solutions, Enterprise Applications, Managed Services, and Talent Solutions. We bring expertise in AI, Data & Analytics, Cloud, IoT, Digital Twins, SAP, and Industry 4.0, along with strong capabilities in regulated environments such as medical devices and life sciences. Driven by agility, quality, and innovation, Intellectt partners with organizations to deliver efficient, compliant, and future-ready solutions that create measurable business impact.
With 30+ years of combined engineering and manufacturing expertise across its
divisions, Intellectt brings deep domain knowledge and execution maturity, enabling clients to
confidently navigate complex, regulated, and high-performance environments.
Flagship Platforms & Accelerators :
Intellectt has developed advanced proprietary solutions and accelerators to drive business
efficiency and innovation, including:
● Voice Connector - enabling seamless, intelligent communication systems
● CCMA (Customer Communication Management & Automation) - delivering
personalized, automated customer engagement at scale
● Enterprise Data Platforms & AI Accelerators - enabling faster deployment of
data-driven and AI-powered solutions
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