Manufacturing Engineer
3 days ago
We are seeking a detail-oriented and process-driven individual to join our team as a Manufacturing Engineer. This role will support our instrument manufacturing operations and is responsible for promoting product quality, supporting instrument manufacturing, and continuous process improvement.
Key Responsibilities:- Support the instrument manufacturing team, working with technicians on complicated electromechanical assemblies.
- Participate in developing, implementing, and monitoring manufacturing quality processes.
- Drive regular review of the manufacturing process to identify opportunities for improvement.
- Participate in the inspection of finished products, in-process assemblies, and raw materials.
- Work with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions.
- Assist in driving timely completion of Non-Conformances while preventing repeat occurrences.
- Partner with operations and quality leaders on the regular review of quality metrics for all instrument manufacturing processes and provide input as appropriate.
- Utilize quality principles and problem-solving skills to address product design and manufacturing issues.
- Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.
- Troubleshoot process problems, define root causes, coordinate implementation of corrective actions, and verify effectiveness.
- Support process and product-related deviation activities, including tracking and trending.
- Support complaint investigations, recordkeeping, and trend reporting.
- Maintain positive and effective communication and collaborate with all levels of the team and outside partners and vendors.
- Bachelor's Degree in engineering-related discipline required, Mechanical or Electrical Engineering preferred.
- Must have strong electromechanical assembly design/manufacturing experience.
- Minimum of 5 years of relevant manufacturing experience in an FDA-regulated environment required, ideally within medical device, in vitro diagnostics, or biotech industry.
- ASQ or Six Sigma Certification or equivalent is desired.
- Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required.
- Must be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations.
- Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred but not required.
- Experience working with Quality Systems compliant with EN ISO 13485 and 21CFR Part 820.
- Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associated with these drawings.
- Must be familiar with relevant inspection techniques and equipment.
- Must have strong technical writing, statistical sampling, and data analysis skills; proficient with Microsoft Excel.
- Must demonstrate sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment, and has strong attention to detail.
- Experience implementing LEAN systems and processes preferred.
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Manufacturing Engineer
3 weeks ago
Lexington, Kentucky, United States Activ8 Full timeAutomotive Parts Manufacturing Company Overview Activ8 is seeking a skilled Manufacturing Engineer to join their team in the Lexington, KY area. This is a full-time, direct hire position with comprehensive benefits. Responsibilities: * Design and develop manufacturing processes and systems to meet production requirements * Collaborate with...
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Manufacturing Engineer
2 days ago
Lexington, Kentucky, United States Jobot Full timeJob OpportunityWe are seeking a highly skilled Manufacturing Engineer to join our team at Jobot. As a key member of our manufacturing team, you will be responsible for designing, developing, and implementing electrical systems for our manufacturing processes.Key Responsibilities:Design and develop electrical systems for manufacturing processes.Collaborate...
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Manufacturing Engineer
4 weeks ago
Lexington, Kentucky, United States Activ8 Full timeManufacturing Engineer Opportunity at Activ8An automotive parts manufacturing company, Activ8, is seeking a skilled Manufacturing Engineer to join their team in the Lexington, KY area.Key Responsibilities:Design and develop manufacturing processes and systemsCollaborate with cross-functional teams to improve production efficiencyImplement quality control...
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Manufacturing Engineer Position
3 weeks ago
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Manufacturing Systems Engineer
3 days ago
Lexington, Kentucky, United States Jobot Full timeJob Title: Manufacturing EngineerOur company, Jobot, is seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for designing, developing, and implementing electrical systems for our manufacturing processes.Responsibilities:Design and develop electrical systems for manufacturing...
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Manufacturing Systems Engineer
2 weeks ago
Lexington, Kentucky, United States Jobot Full timeJob Title: Manufacturing EngineerAre you a skilled Mechanical Engineer looking for a challenging role in a stable and growing company? We are seeking a highly motivated and experienced Manufacturing Engineer to join our team.About the CompanyOur company is a 30-year-old metals manufacturer with a strong reputation for stability, career growth, and excellent...
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Manufacturing Engineer Position
2 days ago
Lexington, Kentucky, United States Jobot Full timeStable Career OpportunityJobot, a 30-year-old metals manufacturer, is seeking an experienced Mechanical Engineer to join our dynamic team. As a key member of our team, you will be responsible for designing, developing, and implementing electrical systems for our manufacturing processes. This includes working with various equipment to improve operational...
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1 month ago
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Manufacturing Process Improvement Engineer
3 weeks ago
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Senior Manufacturing Sciences Engineer
24 hours ago
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Manufacturing Engineer
4 weeks ago
Lexington, Kentucky, United States Jobot Full timeAbout the RoleWe are seeking a highly motivated and skilled Manufacturing Engineer to join our dynamic team at Jobot. As a key member of our team, you will be responsible for designing, developing, and implementing electrical systems for our manufacturing processes.Key ResponsibilitiesDesign and develop electrical systems for manufacturing processes,...
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7 days ago
Lexington, Kentucky, United States Genezen Full timeJob SummaryThe Manufacturing Sciences & Technology (MSAT) group plays a critical role in the successful manufacturing of clinical and commercial products at Genezen. As a Process Engineer I, you will assist the MSAT team in the transfer of technologies, process validation, and cGMP manufacturing of Genezen's gene therapy products.Key ResponsibilitiesAssist...
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Process Engineer I, Manufacturing Sciences
2 days ago
Lexington, Kentucky, United States Genezen Full timeJob SummaryThe Manufacturing Sciences & Technology (MSAT) group plays a critical role in the successful manufacturing of clinical and commercial products. As a Process Engineer I, you will assist the MSAT team in the transfer of technologies, process validation, and cGMP manufacturing of Genezen's gene therapy products.Key Responsibilities:Assist technology...
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1 week ago
Lexington, Kentucky, United States BioSpace, Inc. Full timeJob Title: Manufacturing ManagerAt BioSpace, Inc., we are seeking a highly skilled Manufacturing Manager to join our team. As a key member of our manufacturing department, you will be responsible for overseeing the production process, ensuring quality and efficiency, and driving continuous improvement.About the Role:The Manufacturing Manager will report to...
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4 weeks ago
Lexington, Kentucky, United States Activ8 Full timeWe are seeking a highly skilled Manufacturing Engineer to support the improvement of manufacturing processes and enhance efficiency in our automotive parts manufacturing facility in Lexington, KY.Key Responsibilities:Support the improvement of manufacturing processes to enhance efficiency and reduce downtimeAssist in researching and evaluating new equipment...
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2 weeks ago
Lexington, Kentucky, United States Daltile Full timeJob Title: Manufacturing Plant SupervisorDal-Tile is seeking a highly skilled and experienced Plant Supervisor to join our team. As a key member of our operations team, you will be responsible for leading and managing the production process to ensure safe and quality-driven production.Key Responsibilities:Lead and manage a team of production staff to achieve...
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1 week ago
Lexington, Kentucky, United States Takeda Pharmaceuticals Full timeAbout the RoleWe are seeking a highly skilled Manufacturing Manager to join our team at Takeda Pharmaceuticals. As a key member of our manufacturing department, you will be responsible for overseeing the production process, ensuring quality and efficiency, and driving continuous improvement.Key ResponsibilitiesLead and manage a team of manufacturing staff to...
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2 days ago
Lexington, Kentucky, United States Activ8 Full timeExciting Opportunity at Activ8We are seeking a highly skilled Manufacturing Engineer to join our team at Activ8 in the Lexington, KY area. This is a full-time, direct hire position with a comprehensive benefits package, including 401(k), vision, dental, health, life, and paid time off.About the Role:Design and implement efficient manufacturing processes to...
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Process Engineer
2 days ago
Lexington, Kentucky, United States Acara Solutions, An Aleron Company Full timeProcess Engineer Job DescriptionAcara Solutions is seeking a highly skilled Process Engineer to join our team in Lexington, NC. As a Process Engineer, you will play a critical role in ensuring the efficient and effective operation of our manufacturing processes.Key Responsibilities:Analyze and optimize manufacturing processes to improve efficiency and...
