Sr. Design Engineer/Staff Engineer

Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. 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.
• Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
• User-focused creators. Engineers who design with the user in mind, developing solutions that help change patients’ lives.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What You Will Do:

• 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 GD&T 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.