Senior Device Engineer

Lupin · Bangalore, India

• 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