Qualification:B.Tech In Mechanical Engineering
Salary: Depends On Interview
Selection process: Shortlisted Candidates Will Be Contacted For The Interview
Interact with personnel on technical matters often requiring coordination between organizations.
Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses.
Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF’s)
Initiates change activity (CA) to modify or maintain design documentation (BOM’s, Specs, drawings)
Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership.
Provides RPE input to new product development teams.
Assists regulatory specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications.
Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation.
Collaborates with cross functional partners to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)
Engineering, Sales & Service, Manufacturing, Construction
Permanent, Full Time
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