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 meet 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.
Experience in executing NPD projects involving complete product development life cycle phases form concept to launch.
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, and 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.
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 sheet metals 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.
Good understanding of designing of jigs & fixtures and inspection methods.
