Group Lead – Technical Operations and Services

Lead Activities towards Industrialisation and commercialisation of Medical Devices product. Activities involving Vendor Qualification, Setup manufacturing processes, DFA, DFM, DeX etc. The deliverables of the role are to take the product from POC stage to Manufacturable product, Setting up manufacturing process, Identification and  Qualification of vendors, support Clinical and Regulatory compliance and documentation.

Spends 25% time on working on the product design from POC stage to complete manufacturable product. This includes Design For Manufacturing, Design for Assembly, Design for Excellence, Design Pokayokes, Parts Drawings, Assembly Drawings, Assembly Instructions and Documents Related to Regulatory Compliance.

Spends 25% time is spent on working on Identification of vendors (Tool makers, assembly Contract Manufacturing Organizations (CMO), Electronics Manufacturer and Automation partners),  Evaluation and Qualification of vendors including their Capability, QMS, etc.

Spends 25% time on regulatory filing, import licences, test licence, technical and regulatory documentation, MDR requirements, 510k filing, QMS according to ISO13485, surveillance audits and conversations with notified bodies.

Spends 25% time on Handling products from POC to launch readiness through various activities of cross-functional teams, Handling Product lifecycle Management, Service Model implementation, QMS implementation, market expansions etc.

Expertise in Mechanical engineering/Mechatronics Engineering and familiarly with Product design and scaleup must.

Scaleup

• Device Design for Manufacturing, including comprehensive analysis of part, material, and tool costing, risk assessment, scale-up timelines, selection of Contract Manufacturing Organizations (CMOs), automation strategies for assembly, overall budgeting, cash flow management, and implementation of Design Quality Reviews (DQR), Design for Manufacturability (DFM), and Design for Assembly (DFA) principles.
• Identify potential Contract Manufacturing Organizations, conducted thorough assessments to validate vendor competencies and capacity suitability for specific product requirements

Service

• Setup service models for new products and markets, Handling L1 and L2 resources for service support.
• Trend analysis, service feedback, Post market surveillance, PMCF and all documents related to service and post market responsibilities for Medical device.

Documentation and Regulatory Compliance

• Documentation such as Design Inputs, Outputs, Scaleup, V&V etc. All the necessary documentation required by regulatory submissions for DHF and filings. Also support in product specifications, component certifications, biocompatibility study, robustness study protocols, recording of results etc.

QMS

• ISO 13485 – Documentation, Records, SOPs etc.
• Surveillance audits, Management review Meetings, Site Audits, Scope Revisions etc.
• QMS compliance for all activities, Processes, products at Medtech.

Process – Cost – Engineering Optimisation New Manufacturing Trends and Innovations 

• Optimise Process and Engineering cost to compliment Business requirements.
• Explore and implement innovations/new trends in manufacturing.

• Setting up supply chain for critical manufacturing by validating diverse manufacturing processes.
• Identification of regulatory pathways and documentation for CDSCO, MDR and FDA.
• Setting up critical PLM tools

Internal

• Cipla Medtech team – Product Design team, Procurement team, Usability etc.
• Regulatory, Quality – third party quality, CQA, DQA, Clinical team, Medical team, India and Africa marketing team.

External

• CMO/Manufacturers, vendors, importers, Logistic partners.
• Verification and Validation Labs, certification agencies, ISO certification consultants.

• Degree in Industrial engineering/Mechanical Engineering/Mechatronics Engineering required
• Knowledge of primary regulatory requirements in pharma/MedTech such as 21 CFR, ISO 13485 standards, IEC standards is preferable
• Knowledge of Medical Devices Product Development, Life Cycle Management, Devices PLM must

• Experience at reputed of minimum 8 years in either-in or inclusive-of Manufacturing environment, Product Development Pharma/Med-Tech, Vendor Management.
• Experience in medical device manufacturing (direct operations/team handling) highly welcome