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.

Sr. Design Engineer/Staff Engineer