Us Citizen
Green Card
Corp-Corp
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 8th Jan 2022
This role will lead a new product introduction for screws manufacturing which includes project/program management, process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with new product introduction. Other responsibilities may include: • Provides direction and technical support in identifying continuous improvements to manufacturing operations and implementing new technologies including development of processes, researching current and emerging technologies and evaluating process quality, cost, capacity and capability alternatives. • Provides direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost. • Provides direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation. • Performs assignments designed to continue the development of professional work knowledge and abilities requiring application of standard engineering techniques, procedures and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing. Mentors engineering staff. ENGINEERING DUTIES AND RESPONSIBILITIES: • Participates in multi-site projects. • Leads and participates in complex engineering projects, either technically or with an extensive crossfunctional team. This includes developing and executing to the plan and schedule and meeting the goals and objectives of the project. Tracks costs, prepares status reports, conducts meetings, and documents and communicates progress to management. • Leads and participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA). Performs analysis and communicates associated trends. • Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required. • Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation). • Identifies, leads and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles. • Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
Experience Required Project Manager (PM) with 8+ years of experience managing/leading project implementation
Roles & Responsibilities: Experience in product manufacturing of medical devices involving HW, SW, Test and Integration preferably with RUO/Clinical applications is required Track record in managing projects with regulatory requirements and 510K process – knowledge of ISO13485 / ISO9001 Ability to pro-actively identify project roadblocks and implement countermeasures on time to prevent project delays Experience in managing cross functional teams as Core Team Leader