Sr. Manufacturing EngineerSpectraforce Technologies • Santa Clara, California, United States
Sr. Manufacturing Engineer
Spectraforce Technologies • Santa Clara, California, United States
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job_description.job_card.job_descriptionResponsible for owning process validation activities such as validation protocols and technical reports (POQ, PPQ) Responsible for authoring, execution and reporting for Inspection Method Validations, and Test Method Validations Responsible for assigned line output, safety, yield and quality. Responsible for identification of product defects and determination of operational and process related actions to reduce the defects. This may also include equipment trouble-shooting and subsequent work order request. Works with line support team (QC supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform on line issue triage to evaluate issues and determine if non-conformance is present, determine initial bracketing and containment, and generate corrective actions / preventative actions as needed. Responsible for product / process knowledge and understanding of basic cause and effect of line changes. Considered an expert in statistics, product and Engineering process. Responsible for modeling / drafting assemblies; fixtures & tools; Solidworks mid to advance level. Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implementation). Knowledgeable of procedures related to equipment controls. Support technicians and supervisors in equipment availability issues. Supports Training and Certification Program. Provides additional insight on how to improve trainings and certifications in the best interest of the business. Responsible for determining quality impact of Out-of-Tolerance documents. Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and CR generation related to moderate to complex changes impacting the manufacturing line. Responsible for continuous improvement projects development and execution, including CAPAs implementations. Responsible for exception subtask execution. Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s. Leads CAPA (Major) investigations with data gathering and analysis as needed. Owns CAPA activities without oversight. Be the ME representative for manufacturing related projects including yield, CIP's, productivity, quality and safety. Responsible for coordination of product builds through the NPI process. Leads ME support during external and internal audits. Acts as coach and mentor to more inexperienced engineers or technical personnel. Minimum 5 years Process Validations experience is required. Catheter assembly experience is required. 3-D drawing (Solidworks required). Knowledge and proficiency in the application and principles of Manufacturing / Process Engineering. Knowledge of statistical analysis. Excellent written, verbal and interpersonal communication skills Ability to effectively communicate cross-functionally to assist with resolving Quality / Engineering issues. Basic knowledge of applicable US non-US applicable regulations.
Position Title : Sr. Manufacturing Engineer
Work Location : Santa Clara, California 95054
Assignment Duration : 12 months
Work Arrangement : Onsite
Work Schedule : Mon - Fri 8 AM to 5 PM
Position Summary :
- The Senior Manufacturing Engineer will serve as the primary engineering personnel supporting manufacturing operations including process validation activities.
- The individual performing this role will have strong collaboration with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line. He / She will be accountable on quality, output and yield of the assigned manufacturing line.
Key Responsibilities :
Qualification & Experience :
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Sr Manufacturing Engineer • Santa Clara, California, United States
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