Senior Device Engineer

This role is in Pharma industry thus pharma exposure is must.
Design and development of drug combination products; focused on injectables by understanding design space and managing critical design parameters.
Using design for manufacturing principles as well as geometric dimensioning and tolerance tools to create sound engineering drawings.
Identify the best tools and approaches to effectively solve engineering problems.
To develop, optimize and analyze designs by applying the appropriate mix of engineering principles, analytical, and experimental methods.
Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to solve complex engineering problems. SolidWorks experience is required
Support the evaluation and assessment of new technologies, intellectual property, products, and processes
Support current products in terms of quality, manufacturing, and cost improvement.
Support execution of technical and cross-functional project work.
Write detailed technical reports based on design verification testing for design changes and product design activities.
Conduct due diligence on devices based on business, and regulatory requirements
Develop and implement detailed test methods
Develop realistic and actionable design plans.
Effectively collaborate with laboratory technicians and support staff.
Ensure compliance with Lupin quality policies, standard operating procedures and practices
Must have knowledge of and experience with Factory Acceptance Testing, Process Validation and IQ/OQ/PQ’s.
Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.30
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