Validations Engineer
3 days ago
The Validations Engineer position is primarily responsible for testing the systems used to develop or manufacture our extruded products to ensure the highest quality products are created. This position could also provide general manufacturing support. Troubleshooting problems with production or with customer requirements. These responsibilities require a high competency in communication, project planning and team building. Support new product development activities as directed in the development of Master Validation Plans, PFMEA’s, Control Plans, gauging methodology comparisons, First Article Reports, etc. Conduct and manage product, process, and equipment validations from concept to completion. Write testing protocols and reports. Develop project plans including equipment, personnel, and budgets. Communicate with stakeholders in the process, including customers and other personnel or departments who will be affected by testing. Independently apply analytical skills and tools (like statistical process control, design of experiments, etc.), complex scientific technical principles, and detailed knowledge in solving engineering problems Perform Measurement System Analysis (MSA). Support new product quoting and development and ongoing production needs with product specification review of the customer specified tubing components. Develop and/or improve and implement procedures and work instructions in current quality system. Ability to fulfill Spectrum Plastics Group’s Quality Statement goals and complete documentation within quality system requirements. Perform product measurement and testing. Ability to detect quality defects. Complete other duties as assigned. Qualifications Candidate Requirements: Bachelor’s degree in engineering (or related technical field). Prefer 3 years’ experience in extrusion. Prefer 3 years’ experience in the Medical Device field. Knowledge of ISO 9001, ISO13485 and GMP standards. Ability to read technical documents and drawings. Familiarity with plastic materials. Strong statistical skill set. Strong Technical writing. Proficiency in Excel, Minitab or equivalent. Bilingual: Spanish/English is a plus. Professional working experience with medical device design and manufacturing technologies and/or products. Experience with Test Method development, protocol generation, execution, and reporting. Experience mentoring junior members of the technical staff. GMP and ISO 9000 training. Experience with tooling design with advanced SolidWorks CAD knowledge. Preferred but not required. Understanding of materials associated with medical devices such as polymers (PVC, nylons, polyethylene, polycarbonate, polypropylene. Understanding of polymer extrusion processes and equipment including medical polymeric materials, diameters ranging from 0.030” to 1.0” diameter parts, single and multi-lumen profiles, para-tubing, co-extrusion applications, bump tubing, striping, etc. Understand customer requirements and applications. Six Sigma Greenbelt or equivalent certification beneficial but not required. 25% travel. Competencies/Skills • Self-motivation and hands-on skills to simplify complex processes. • Capability to establish change and encourage the inter-organizational exchange of skills. • Excellent communication and interpersonal skills combined with the ability to interact with and influence all levels of the business and clients. • Good problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision-making.
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Validation Engineer Lead
20 hours ago
Pleasant Prairie, Wisconsin, United States Spectrum Plastics Master Full timeAbout the RoleWe are seeking a highly skilled Validation Engineer Lead to join our team at Spectrum Plastics Master. This role will be responsible for leading the development and implementation of quality control procedures, as well as conducting and managing product, process, and equipment validations.The ideal candidate will have a strong background in...
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Validation Engineering Manager
1 month ago
Pleasant Grove, United States PURA, Inc. Full timeValidation Engineering Manager Join Us at Pura—Reimagining Fragrance for the Future At Pura, we believe life is better when it smells good. Fragrance has the unique power to transform spaces, elevate moods, and create lasting memories. But we know it can do even more. That’s why we’re pioneering the future of fragrance, combining cutting-edge smart...
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Validation Engineering Manager
4 weeks ago
Pleasant Grove, United States PURA, Inc. Full timeValidation Engineering Manager Join Us at Pura-Reimagining Fragrance for the Future At Pura, we believe life is better when it smells good. Fragrance has the unique power to transform spaces, elevate moods, and create lasting memories. But we know it can do even more. That's why we're pioneering the future of fragrance, combining cutting-edge smart home...
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Eden Prairie, United States ACIST Medical Systems Full timePrincipal Software Verification and Validation Engineer LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies? At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose...
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Mechanical Test/Validation Engineer Specialist
3 weeks ago
Pleasant Grove, Utah, United States Pura Full timeJob OverviewPura, a leading innovator in smart home fragrance technology, is seeking a skilled Mechanical Test/Validation Engineer Specialist to join our team.This role is a key part of our mission to redefine the way people experience scent and make it an integral part of their daily lives. As a Mechanical Test/Validation Engineer Specialist, you will play...
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Senior Process Engineer
3 weeks ago
Pleasant Prairie, United States Spectrum Plastics Master Full timeDrives technological improvement activities and process improvement activities. Creates and implements new products/processes, improves productivity, reduce customer complaints, and reduce costs. Coordinates implementation of new capital manufacturing equipment and processes to optimize production and increase capacity. Drives improvements to reduce scrap,...
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Senior Scent Design Validation Manager
3 weeks ago
Pleasant Grove, Utah, United States Pura Full timeWe are seeking a Senior Scent Design Validation Manager to join our team at Pura, a pioneering company in the field of smart home fragrance technology. As a key member of our engineering team, you will be responsible for overseeing the validation of our scent design products to ensure they meet the highest standards of quality and performance.Company...
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Software Verification and Validation Expert
20 hours ago
Eden Prairie, Minnesota, United States ACIST Medical Systems Full timeJob Overview: ACIST Medical Systems is seeking a highly skilled Principal Software Verification and Validation Engineer to join our global R&D software engineering organization. This key member of the software development team will develop verification and integration test software across the product portfolio, ensuring compliance with regulatory...
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Process Engineer-Tubing Extrusion
3 weeks ago
Pleasant Prairie, United States Spectrum Plastics Master Full timeProcess Engineer – Tubing Extrusion is responsible for Execution and implementation of projects of great impact for the organization, related to cost reduction and improvements in the company's productivity. Analysis and solution of critical problems for the operation assigned by the plant. Provides technical support on complex problems to extrusion...
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Extrusion Process Expert
11 hours ago
Pleasant Prairie, Wisconsin, United States Spectrum Plastics Master Full timeJob OverviewSpectrum Plastics Master is seeking an experienced Extrusion Process Expert to join our team. This role will be responsible for developing and implementing quality control procedures, as well as conducting and managing product, process, and equipment validations.The ideal candidate will have a strong background in engineering, with a focus on...
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System Protection Engineer
7 days ago
Grand Prairie, Texas, United States Lockheed Martin Corporation Full timeThe RoleIn this position, you will have the opportunity to work on high-integrity, security, and safety-critical embedded systems. You will be responsible for providing embedded system security engineering design and implementation in all aspects of system security engineering (SSE) process in development of Department of Defense (DoD) weapon systems.You...
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Aerospace Engineer Opportunity
7 days ago
Grand Prairie, Texas, United States Lockheed Martin Corporation Full timeLockheed Martin Corporation OverviewThe Lockheed Martin Corporation is a leading global security and aerospace company with approximately 114,000 employees worldwide. We are primarily engaged in the research, design, development, manufacture, integration, and sustainment of advanced technology systems, products, and services. Our Missiles and Fire Control...
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Scientific Lead in Parenteral Manufacturing
1 week ago
Pleasant Prairie, Wisconsin, United States Eli Lilly Full timeAt Eli Lilly, we unite our passion for innovation with a commitment to excellence, making life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees worldwide collaborate to discover and bring life-changing medicines to those who need them, improve the understanding and management of...
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Calibration Specialist
4 weeks ago
Pleasant Prairie, Wisconsin, United States Eli Lilly Full timeAt Eli Lilly, we're dedicated to improving the understanding and management of disease. Our team is looking for a skilled Calibration Specialist to join our Metrology group.Job SummaryThe Calibration Specialist will be responsible for installing, calibrating, repairing, and maintaining instrumentation used in the manufacturing, testing, and storage of...
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Embedded Systems Protection Engineer
7 days ago
Grand Prairie, Texas, United States Lockheed Martin Corporation Full timeAbout Lockheed Martin CorporationWe are a leading technology innovation company that partners with customers around the world to bring proven performance to their toughest challenges. Our customers tackle the hardest missions, demanding extraordinary amounts of courage, resilience and precision. They're dangerous. Critical. Sometimes they even provide an...
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Eden Prairie, Minnesota, United States Manpower Engineering Full timeJob Title: Mechanical Engineering Leader for Product Development and Sustaining EngineeringLocation: VariesAbout Manpower Engineering:We are a global workforce solutions company with a passion for innovation. We work on cutting-edge projects across various industries, including medical devices.Salary Range: $120,000 - $160,000 per yearJob Description: As a...
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Data Engineer II
3 weeks ago
Eden Prairie, United States E. A. Sween Company Full timeWhat We’re Seeking:E.A. Sween Company is seeking an experienced Data Engineer II to enhance our data infrastructure and contribute to strategic data initiatives. As a Data Engineer II, you will play a pivotal role in designing, building, and maintaining advanced data pipelines and systems that support the growing needs of our organization. This role...
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Data Engineer II
3 weeks ago
EDEN PRAIRIE, United States E. A. Sween Company Full timeWhat We’re Seeking: E.A. Sween Company is seeking an experienced Data Engineer II to enhance our data infrastructure and contribute to strategic data initiatives. As a Data Engineer II, you will play a pivotal role in designing, building, and maintaining advanced data pipelines and systems that support the growing needs of our organization. This role...
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Quality Engineer
3 weeks ago
Mt Pleasant, United States Hitachi Energy Full timeReference #: R0067134 General Information: Hitachi Energy is seeking for a Quality Engineer for it's Mount Pleasant, PA location. Your Responsibilities: Follow safe work practices, comply with policies and procedures, proper and safe use of equipment and tools, and identify and report unsafe working conditions. Perform statistical evaluation to validate and...
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Design Engineer
3 days ago
Pleasant Hill, United States Eticeng Full timePrincipal Civil Design Engineer, Water/WastewaterETIC, an established and growing mid-size consulting, engineering and construction company in the East Bay Area, is seeking a seasoned Principal Civil Design Engineer.Essential Duties and Responsibilities:Build a practice and serve as the practice lead for a civil engineering design business line focused on...