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Engineer / Sr. Engineer - Research & Development (New product Development)
1 week ago
:
New products development and support sustenance activities for existing products using design control processHands on experience in functional and simulated use tests of medical devices, test methods development and knowledge on maintenance of lab equipment, calibration is desirable.
Understanding & good knowledge of various standards such as ISO 13485, ISO 14971, ISO 3826, ISO 10993, ISO 15223 etc.
Ability to perform Gap assessment for standards and prepare equivalency reports. Experience in facing regulatory body audits on design control process would be beneficial, but not mandatory.Identify the problem and perform root cause analysis for failures. Knowledge in analysis using QC tools would be highly beneficial.
Support Design verification activities with protocol and report preparation.
Statistical analysis of data for investigating trends, patterns, and relationships using quantitative dataPreparation and periodic update of labels, drawings and specifications as and when necessary for both local and global sites.
Working collaboratively with all stakeholders in Penpol operations team and from other R&D sites across the globe.Create and update standard operating procedures (SOP) employed in new product developmentSupport prototype, sample and design verification builds and coordinate activities with other departments including production, planning, procurement, stores, logistics etc.
Good understanding of product life cycle managementSoftware:
AutoCAD, SOLIDWORKS, Minitab, CorelDRAW, MS office, ExcelQualification
:
Bachelor's or Master's degree in Engineering or ScienceExperience
: 1-3 years in Medical device industry, preferably involved in design and development
Job Segment:
R&D Engineer, R&D, PLM, Testing, Engineering, Research, Management, Technology
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Thiruvananthapuram, Kerala, India Terumo BCT Full timeEngineer / Sr. Engineer - Research & Development (New product Development) Job Description : New products development and support sustenance activities for existing products using design control process Hands on experience in functional and simulated use tests of medical devices, test methods development and knowledge on maintenance of lab equipment,...
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