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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # GIS Team Member - GISTM - **Company:** Ipolarity LLC - **Location:** Cincinnati, OH, United States - **Experience:** Expert - **Salary:** $27,040.0 - $30,160.0 - **Contract:** Permanent contract - **Skills:** Microsoft Windows, Software Applications, Text Processing, Failure Mode Effects Analysis, Iq/oq/pq - **Published:** August 10, 2026 - **Apply:** https://www.careerjet.com/jobad/us7d54d55826e065e4e3043e53cddee32e ## About the Role Bachelor in Mechanical Engineering or equivalent with 5-10 year s experience in manufacturing process and operations. ## Description Manufacturing Process Engineer with 5-10 years of experience in manufacturing engineering and operations within the medical device industry. Responsible for driving process improvements, supporting manufacturing operations, and delivering engineering solutions that improve quality, safety, productivity, and cost efficiency. Experience in process development, validation (IQ/OQ/PQ), PFMEA, CAPA/NCR management, tooling and fixture development, material validations, and QMS compliance. Proven ability to optimize manufacturing processes, reduce waste, support supplier validations, and ensure regulatory compliance in a highly regulated environment. Responsibilities : Mechanical Engineering with experience in manufacturing process and operations. Support attainment of key business metrics through the provision of engineering support for value stream processes. Elimination of safety and quality risks in the process through the delivery of robust engineering solutions. Machinery maintenance system support activities for equipment and fixtures. Manage costs through the delivery of scrap, reprocessing and consumable reduction projects. Modify & Develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors. Develop stable and capable manufacturing process through a structured process development approach. Perform scrap and cost analysis based on evaluation of manufacturing process for minimizing waste and maximizing production. Ensure all process development, validation (IQ, OQ, PQ) etc. is managed in accordance with the Quality management system (QMS). Perform Risk Assessment on the process of development to highlight potential failure modes and evaluate identified risks using PFMEA. Preparation of all relevant manufacturing specifications. Competent in validation requirements for new consumables/materials and process changes. Update and maintenance of manufacturing specifications for process steps. Ensure timely closure of quality actions such as Audit Actions, NCR s, CAPA s. Ensure all process development, validation, etc, is managed in accordance with the Quality management system. Personal computer software Windows: word processing, project planning, presentation, e-mail. Implemented laboratory controls in the polymer lab based on internal regulatory compliance standards. Materials R&D SME/DRI for material supplier validations: analyzed supplier data, authored protocols and coordinated test specimens, and updated material specifications Top Skills: Manufacturing Process Development | Process Validation (IQ/OQ/PQ) | PFMEA | CAPA | NCR | QMS | Risk Assessment | Manufacturing Operations | Tooling & Fixture Development | Scrap Reduction | Cost Optimization | Continuous Improvement | Medical Device Manufacturing | Supplier Validation | Root Cause Analysis, Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved. ## Related Videos - [Fake or News: Translating Dog Barks, Notepad Gets an Upgrade and Michelin-Star Robots - Paul Tregoing](https://www.wearedevelopers.com/videos/1802-fake-or-news-translating-dog-barks-notepad-gets-an-upgrade-and-michelin-star-robots-paul-tregoing) - [A beginner’s guide to modern natural language processing](https://www.wearedevelopers.com/videos/858-a-beginner-s-guide-to-modern-natural-language-processing) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [How Lufthansa Industry Solutions is preparing for the Quantum Age! ](https://www.wearedevelopers.com/videos/1443-how-lufthansa-industry-solutions-is-preparing-for-the-quantum-age) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Multilingual NLP pipeline up and running from scratch](https://www.wearedevelopers.com/videos/901-multilingual-nlp-pipeline-up-and-running-from-scratch) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers) - [Dev Digest 120 - Apple and peers](https://www.wearedevelopers.com/magazine/455-dev-digest-120-apple-and-peers) - [Dev Digest 119 - ❤️ === ❤️](https://www.wearedevelopers.com/magazine/454-dev-digest-119) - [Dev Digest 182: GPT5 Prompts, MCP Vulnerabilities, Code Traps](https://www.wearedevelopers.com/magazine/622-dev-digest-182-gpt5-prompts-mcp-vulnerabilities-code-traps) - [Dev Digest 183: End of Win10, a Bus Factor of 0, "Call" Explained](https://www.wearedevelopers.com/magazine/624-dev-digest-183-end-of-win10-a-bus-factor-of-0-call-explained)