Sr Engineer/Scientist - Material Technology

Position Summary:

Job Title: Sr Engineer/Scientist - Material Technology

Industry: Medical Devices

Work Location: Bangalore

Years of Experience 5 to 7 years

Roles & Responsibilities:

• Independent contributor providing technical expertise on materials relating to composition, characterization and performance evaluation.
• Ability to define and conduct material assessments, test methods, sampling plans, shelf life, storage conditions and related material acceptance requirements.
• Author and review technical rationales/memos/stability documentations.
• Evaluate material specifications changes to support design change and lifecycle management activities.
• Lead material- related change control activities, including change task creation, change order development and implementation
• Collaborate with cross-functional teams to drive change control process and support material evaluations.
• Exhibit strong problem solving and technical knowledge
• Strong risk management background, including familiarity with tools and approaches such as FMEA, CTQ flowdown, risk assessment, impact analysis, mitigation planning, and traceability of technical risks to material specifications and product quality requirements.

Experience with WCH products is preferred

Requisite Abilities and Skills:

Experience:

Medical devices products, wound closure and healing

Desired Education Qualification:

Material Science/Engineering background B.E./ B. Tech/M.Tech _Any of (Chemistry, Chemical Engineering, Polymer Engineering/Plastics/ Materials/Metallurgy)

Tools: MS Office, Microsoft Project, PLM (Windchill)

Required Skills

• Relevant work experience in polymers
• Material-related Strategies - Create / follow processes and procedures to assist material related strategies for defining raw material shelf-life/ storage condition and material assessment
• Material Assessment - Assessment of materials for hazardous substances. Working on REACH, SVHC, PFAS and other hazardous substance management as per EU/ US regulation
• Understanding of ISO 13485, FDA21 CFR Part 820, medical device manufacturing requirements, GDP/GMP
• Thorough understanding and experience in diverse types of materials, structural properties & material stability-
• Technical Memo writing experience
• Creating a database for material supporting documents used in building rationales, shelf-life forecast etc.,
• All Activities must be performed in compliance to the Medical Quality Systems
• Experience in Change management activities related to Raw Materials
• Experience in design control processes
• Ability to assess raw material changes on materials CTQ, product performance, safety, manufacturing, regulatory compliance, design and validation activities
• Exposure to change order creation and routing the documents in PLM