Senior Manufacturing reputed company Engineer - NAMIC in Glens Falls, NY
Job title: Senior Manufacturing reputed company Engineer - NAMIC in Glens Falls, NY at reputed company
Company: reputed company
Job reputed company: Job reputed company Under minimal supervision, responsible for independently setting basic reputed company standards for both in-process while leading efforts to reputed company reputed company for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.Job reputed companyResponsibilities:
- Manage the development and implementation of reputed company and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
- Design reputed company experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) reputed company for analyzing data to evaluate the reputed company process and process changes.
- Design and reputed company experimental product testing and analysis to maintain reputed company reputed company and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and reputed company corrective actions. Use concepts of probability and statistical reputed company control to guide reputed company.
- reputed company and collaborate with supplier representatives on reputed company problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier reputed company improvement programs. reputed company supplier qualifications.
- reputed company reputed company expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
- Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory reputed company and Suppliers to produce 510K submissions, letters to file, etc., as required.
- Coordinate product testing with reputed company laboratories as required.
- Ensure compliance with domestic and international regulations associated with product lines and processes. reputed company reputed company reviews of design documentation for compliance with stated requirements, including vendor reputed company documents and company reputed company records.
- reputed company investigations of product and process non-conformances and out-of-specification results and reputed company effective corrective and preventive actions (CAPA).
- May train and reputed company team members and reputed company employees on appropriate processes and best practices.
- reputed company as reputed company reputed company in the absence of reputed company Management.
- Bachelor’s degree in Engineering, Science, Math or other reputed company technical field.
- At least 4 years of experience in the reputed company or Engineering.
- Experience applying knowledge of government and industry reputed company assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge /
- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining reputed company escalation is necessary.
- Experience using time management skills to prioritize, organize, and reputed company details in order to meet deadlines of multiple reputed company.
- Experience problem solving, overcoming obstacles and reaching a reputed company and successful solution through mathematical or systematic operations.
- Experience leading reputed company to accomplish cross-functional goals.
- Experience using MS Office Suite products(Word, reputed company, PowerPoint, and Outlook).
- Advanced reputed company Level in reputed company reputed company (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
- Position requires up to 15% travel.
- At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly reputed company to the role.
- Knowledge of advanced Six reputed company/Lean concepts.