Team member - POC standalone devices

Division

Department

Sub Department 1

Job Purpose

This role leads in the development, validation, engineering, prototyping, and demonstrating a working, compact and compliant device product which is ready for scale up and tech transfer. Primary deliverable of the role is to ensure that from the design concept, the actual product, it™s detailed engineering, and detailed elements of design of that product are ready for scale up and quality assurance. 

The role spends 70% time on finetuning, demonstrating, and detailing the designs developed by the design engineer to bring a minimum viable product, prototypes for the review of development teams, IPD leaders and quality department.   

Rest 30% time is spent on working with Tech transfer, mould expert, regulatory compliance, and verification roles to ensure the quality by design elements are embedded in the POC product.  

Key Accountabilities (1/6)

Device design and development blueprint

• Define a target product profile (TPP) for the product under consideration with all stakeholders from IPD, marketing, medical, quality, regulatory and supply chain.
• Build the detailed development plan to achieve this TPP by considering the primary    

Key Accountabilities (2/6)

Design for manufacturing, design for quality and design for safety establishment  

Lead and provide expertise to input regulatory and QA functions requirements on manufacturing and quality of the product including limits of safety, part wise material of construction, biocompatibility requirements by market etc. and arrive at a design and a functional prototype that can meet these predefined criteria at the R&D stage.

Key Accountabilities (3/6)

Detailed product toolkit for scale up with demonstrated minimum viable product

• Define a detailed design, production ready drawing of each of constituent parts, preliminary assembly process and quality attributes
• Construct a minimum viable product/s, test it in the IPD, in the pilot setting and with select doctors to iterate on the functional, design and interface feedbacks
• Develop novel technologies such as vacuum casting to build small batch (a set of) functional samples which can be used in the pilot testing, scale up process creation and manufacturing contract signings with the vendor partners.

Key Accountabilities (4/6)

Device acceptance and validation scheme including quality by design matrix

• Build quality metrics of the product design, QBD map and corner point (stress condition) analysis including acceptance limits keeping in mind safety, efficacy, cost and technical feasibility of the product
• Work with Validation associates, QC, Regulatory team to build relevant certifications of quality, safety and marketability for the product
• Keep track of device wise ergonomic and design for performance iterations undertaken to achieve minimum viable product and document these technical specifications at each stage for quality assurance in final design

Key Accountabilities (5/6)

Clean sheet costing, target costing and supply chain viability analysis

• Define the clean sheet cost for the product developed at the R&D stage, scale up stage and target commercial stage
• Finalize bill of materials, assembly operations to deliver low cost, high value product design which is scalable and rapidly manufacturable
• Conduct supply chain Strength and Weakness analysis on each of the component to ensure lifecycle sustainability, environmental footprint and uninterrupted supply

Key Accountabilities (6/6)

Major Challenges

• Delay in development of a functional product which can meet the Target Product Profile thereby a loss of revenue to the organization in absence of the production ready device
• Trade-off between designs with low cost vs. the maximum safety and quality vs. the simplistic but large number of items and high complexity of supply chain
• Technology to build minimum viable product which can be worked upon, tested or verified
• Managing multiple POC projects while balancing individual quality and safety standards and documentation concurrency

Key Interactions (1/2)

Internal

• Cipla Devices team “ device design understanding, critical quality attributes, tech transfer attributes 
• Regulatory “design file, regulatory query resolution on prototype samples submitted for evaluation
• Marketing and medical- defining TPP, providing preliminary prototypes, evaluating pilot testing and feedback

Key Interactions (2/2)

External

• Mould manufacturers “ scope, timeline and mould development management, FOT (Regular basis)
• Regulatory and quality consulting bodies on standards of quality and safety testing
• CROs for biocompatibility and other relevant certifications

Dimensions (1/2)

1. Device Design for Manufacturing report “ details out part wise, material wise, tool wise costing, risk profiles, scale up timeframes, CMO choices, automation scheme for assembly and overall budgeting and cash outflow timings for the organization, typical value at stake is 15-30 Million USD.
2. Device verification report accepted by Manufacturing Quality and DQA “ For the first to file approval, this is a critical milestone required to be achieved. Verification in terms of all design, process and scalability parameters is expected to be designed, recorded and approved from QA function.

Dimensions (2/2)

Key Decisions (1/2)

Key Decisions (2/2)

Education Qualification

• Master™s degree in mechanical/plastic engineering/instrumentation required
• Knowledge of primary regulatory requirements in pharma such as 21 CFR, ISO 13485 standards, IEC standards is preferable
• Knowledge of Polymers, injection moulding, CAD, tolerance analysis required

Relevant Work Experience

• Experience at reputed medical device or healthcare product development company for minimum 6 years in device development, design, production engineering
• Experience in implantable, diagnostic, or monitoring devices highly welcome