01What 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/Bachelors 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 .
