Ranjithkumar Subramani

• Managing end-to-end projects from Planning, Coordinating, resource allocation, stakeholder management, execution, resource utilization, and delivery based on agreement and timelines with Quality.
• Strong leadership and decision-making skills with minimal support; appraising ongoing situations by effective communication methods.
• Extending technical support to project teams on Quality processes and procedures. Developed, reviewed, and distributed templates and tools to guarantee process alignment.
• Addressing design challenges and evaluating alternative design models to meet project requirements.
• Developing the test method protocols and completing the test summary report and closure.
• Leading the DHF remediation activities and performing the SME review.
• Leading the Complaints handling and Medical device reporting projects and playing the role of the Product owner to handle the product quality.
• Supporting software documentation for SamD according to IEC 62304 and participating in the Software Lifecycle processes.

• Lead and manage Product, Process quality, Safety, Improvement, and Reliability in projects to optimize processes.
• Partnered with Project team members and Cross-functional teams to identify the risks and quickly address problems.
• Overseeing the process and product audits, addressing the non-compliance and compliance to prepare the CAPAs.
• Conducted the product risk assessment for products launched in the market. Analyzing the market feedback based on post-market surveillance.
• Executed the Use error analysis.
• Reviewed the DHF and was actively involved in Design Control activities for Orthopedic instruments and implants.

• Handled various sustaining projects, supplier transfer projects, and MDR regulatory compliance projects.
• Supported MDR regulatory Design and Drawing specification updates for 8k product codes.
• Authored and Reviewed TF and DHF Design control documents for EU MDR and US FDA requirements.
• Participated in cross-functional team reviews to develop periodic safety update reports, post-market surveillance plans, product risk management files (risk management plan, risk assessments, DCRM, and risk management report).
• Setup Product Variants in ERP and PLM to maintain the Different Design Specification.
• Handled the detailed design and development of class I, II, and III devices in Orthopedic product groups.
• Expert in CAD modeling and Tolerance analysis.
• Performed the UDI assessments and ensured the Data in PLM and ERP setups.

• Review of Technical Verification and Validation reports and involved in Validation activities and test reports with cross-functional teams.

– IQ, OQ, and PQ preparation from scratch.

– Executed and Reviewed PQP, FAI inspection plan, and reports.

– Ensured the Process Verification and Evaluation.

– Worked on Prospective Validation.

• Active participation in Design reviews to ensure all medical quality standards and metrics are achieved.
• Reviewed Risk documents, plans, and reports, conducted at the developmental stages of products and processes also based on the ISO 14971 requirements.
• Advising the team to adhere to Good documentation process (GDP) and Good Manufacturing Process (GMP).

• Driven the Multiple NPI´s and line extension projects in Graphic cases.
• Performed the Tolerance Stack up analysis, Drawing Reviews and Simulation testing as a Verification support for New Products and line extensions.
• Authored the various DHF deliverables, start from D&D plan, Functional Design requirements, Design Input / Output Reports, Product safety risk assessments and Design transfer plans.
• Collaborating with Instruments and Implant core teams to set up the layout requirements for Graphic cases and trays.

• Designed and launched new products and variants in BIS Safes and BIS Strong room doors according to IS 550 and IS 11138.
• Prepared the Technical documents for BIS product submissions.
• Created the effective nesting in the Laser programs with the help of Solid works and Trump Laser DXF Tools and reduced the wastages from sheets.
• Designed the Receiving gages based on Gage R&R techniques.
• Drafted documentation detailing design requirements and technical specifications.

• Developed the customized designs in the conventional Injection Molding higher tonnage machines based on the work orders.
• Designed the automated gate systems in the higher tonnage Injection Molding machines.
• Prepared the user manual.
• Designed the mechanical parts required to fabricate the Injection Molding machines.

• Designed automobile components (flywheel, brackets, wheel hubs etc.). Conducted the Production Part Approval Process (PPAP) for new products, based on customer designs.
• Creating drawings and 3D Models. Performing tolerance stack-up analysis and Validation activities
• Performing the quality inspection and reviews.