Sr. Design Engineer/Staff Engineer

• Design development of mechanical components systems in the medical device domain.
• Working on multiple projects simultaneously in product engineering such as gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc.
• Derive or remediate design requirements/engineering specifications (including performance, reliability, etc.) that meets the user need requirements.
• Creation or remediation of Design History Files, Device Master Records and other related technical documents including drawings, labelling, packaging, instruction for use, etc.
• Driving the engineering changes through proper planning analysis of change impact, creation of change orders/notices applicable documents, execution of change for implementation through multiple review processes coordinating with various stakeholders involved.
• Engineering analysis through simulation, design of experiments, statistics, engineering calculations, etc.
• Liaison with lab team to carry out verification and validation activities that include the development of test methods, test protocols, test method validation, test execution, analysis, and reporting.
• Collaboration with divisional partners to drive the assigned projects within schedule, cost quality baselines.
• Involve in technical discussions with the stakeholders (including SMEs, vendors, etc.) globally.
• Execution of NC CAPA implement design controls risk controls.

What You Need:

• Master/Bachelor s in Engineering, Mechanical Engineering
• 3+ years of work experience
• Strong technical ability in creating engineering drawings and models, applying GDT and CAE tools.
• Skilled in interpreting design, analyzing, and doing DFM, DFI, materials and manufacturing
• Adept at applying knowledge of materials and manufacturing processes to product design.
• Ability to communicate moderate complexity plans and technical information to team members.
• Experience knowledge of plastic films and film blown extrusion process preferred.
• Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics)
• Experience with analysis tools, specifically tolerance analysis and FEA using ANSYS software preferred.
• Strong knowledge of soft goods(textiles) and plastic parts design, manufacturing, and testing methods.
• Understanding of engineering change process with prior experience in creating engineering change notices or orders, conducting design or change reviews and implementing them.
• Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab, etc.
• Experience in working with regulated industries like Medical devices, Aerospace, Automotive etc. Understanding of medical device standards and regulations is preferred.
• Highly developed problem-solving skills with demonstrated successful resolution of project-level issues.