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 fastpaced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. Engineers who seek out cuttingedge research and information to expand and enhance their ability to develop software.
Goaloriented developers. Keeping the customer and system requirements squarely in focus people who deliver safe and robust solutions.
Userfocused creators. Engineers who design with the user in mind developing solutions that help change patients lives.
Collaborative partners. People who build and leverage crossfunctional 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 businessdriven 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 devices Aerospace Automotive etc. Understanding of medical device standards and regulations is preferred.
Highly developed problemsolving skills with demonstrated successful resolution of projectlevel issues.
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