Jervis Vasanth J

(Aug 2022 – Mar 2024)

• Supported design change activities using Abbott’s Viewpoint system by updating engineering documents, drawings, specifications, and technical files.
• Created and routed Change Orders (COs) through the full approval workflow, ensuring compliance with FDA QSR, ISO 13485, and internal design control procedures.
• Utilized Windchill PDLM for product lifecycle management, version control, and maintaining design traceability.
• Ensured engineering changes aligned with product performance, safety, and usability requirements.
• Conducted Product Knowledge Transfer (PKT) sessions to mentor team members on product function, subsystems, and engineering processes.
• Collaborated with design, quality, and manufacturing teams to support technical evaluations and documentation updates.

(Mar 2024 – Present)

• Work extensively on Subsystem Requirements (SSyR), LCVP, and Design Input (DI) documents as part of Baxter’s design control process (21 CFR 820.30).
• Own the complete Change Control process for the Baxter → Vantive transition, ensuring product design documents meet regulatory, quality, and safety expectations.
• Lead impact assessments for engineering changes across: Product design, Quality and QMS, Risk Management (ISO 14971), Verification & Validation (V&V), Labeling and marketing, Regulatory & MDR compliance.
• Support MDR remediation by updating risk files, DI documents, labeling, and technical documentation for EU submissions.
• Ensure design traceability from user needs, design inputs, subsystem requirements, and risk controls.
• Coordinate with cross-functional teams (Design, Quality, RA, Validation, Manufacturing) to ensure that engineering changes maintain product safety, performance, and reliability.
• Review engineering changes, and ensure the product is compliant and ready for release/distribution to multiple global markets.
• Contribute to the continuous improvement of design control processes, documentation clarity, and risk mitigation strategies.