Sr. Design Engineer/Staff Engineer
Full-timeSeniorMasters
Description
Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><div><div>Job Description</div></div><div><div><div><div><p><b><u><span>Who we want:</span></u></b></p><ul><li><b>Analytical problem solvers.</b> People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.</li><li><b>Dedicated achievers.</b> Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.</li><li><b>Curious learners</b>. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.</li><li><b>Goal-oriented developers</b>. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.</li><li><b>User-focused creators.</b> Engineers who design with the user in mind, developing solutions that help change patients’ lives.</li><li><b>Collaborative partners</b>. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.</li><li><b>Motivated product launchers</b>. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.</li></ul><p></p><p><b><u><span>What You Will Do:</span></u></b></p><ul><li>Design & development of mechanical components & systems in the medical device domain.</li><li>Working on multiple projects simultaneously in product engineering such as gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc.</li><li>Derive or remediate design <span>requirements/engineering</span> specifications (including performance, reliability, etc.) that meets the user need requirements.</li><li>Creation or remediation of Design History Files, Device Master Records and other related technical documents including drawings, labelling, packaging, instruction for use, etc.</li><li>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.</li><li>Engineering analysis through simulation, design of experiments, statistics, engineering calculations, etc.</li><li>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.</li><li>Collaboration with divisional partners to drive the assigned projects within schedule, cost & quality baselines.</li><li>Involve in technical discussions with the stakeholders (including SMEs, vendors, etc.) globally.</li><li>Execution of NC CAPA implement design controls & risk controls.</li></ul><p></p><p><b><u><span>What You Need:</span></u></b></p><ul><li>Master/Bachelor’s in Engineering, Mechanical Engineering</li><li>3+ years of work experience</li><li>Strong technical ability in creating engineering drawings and models, applying GD&T and CAE tools.</li><li>Skilled in interpreting design, analyzing, and doing DFM, DFI, materials and manufacturing</li><li>Adept at applying knowledge of materials and manufacturing processes to product design.</li><li>Ability to communicate moderate complexity plans and technical information to team members.</li><li><span>Experience & knowledge of plastic films and film blown extrusion process</span> preferred.</li><li>Good working knowledge of CAD applications <span>(Creo/SolidWorks/UniGraphics)</span></li><li>Experience with analysis tools, specifically tolerance analysis and FEA using ANSYS software preferred.</li><li>Strong knowledge of soft goods(textiles) and plastic parts design, manufacturing, and testing methods.</li><li>Understanding of engineering change process with prior experience in creating engineering change notices or orders, conducting design or change reviews and implementing them.</li><li>Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab, etc.</li><li>Experience in working with regulated industries like Medical devices, Aerospace, Automotive etc. Understanding of medical device standards and regulations is preferred.</li><li>Highly developed problem-solving skills with demonstrated successful resolution of project-level issues.</li></ul></div></div></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>