Manufacturing Engineer
1 week ago
Job Description: C**** *** ****** Incubation Center collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new products. The Sr. Manufacturing Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable, utilize best technologies, reflect standard work, are capable and compliant with Regulatory requirements, and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Sr. Advanced Manufacturing Engineer will act as a liaison between R&D, Supplier Development, Quality, and Operations team members assigned to the project. Key Responsibilities (“Do”): • Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging. • Produce production-level assembly and part drawings for all components and sub-assemblies. • Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization. • Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers. • Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships. • Act as the liaison between Contract Manufacturing Organization (CMO) and C***** to coordinate manufacturing activities as directed by Management. • Review engineering product specifications and CAD data/drawings as part of the design review process to ensure they meet industry and manufacturing standards and practices. • Responsible for part/drawing release and the accuracy of the Bill of Materials (BOM). • Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports. • Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing. • Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans. • Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls. • Coordinating technical communications between C**** and contract manufacturers, including design transfer. • Providing technical expertise in conducting pFMEA and developing process validations. • Sharing expertise in Lean Six Sigma process excellence principles. • Collaborating with cross-functional product development teams, including project managers, optical engineers, mechanical engineers, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others. • Results Expected (“Deliver”): • Development and maintenance of project task list for DFM Activities • Create and maintain up-to-date BOMs, work instructions, and travelers. • Creation and maintenance of pFMEA Qualifications: • Education: bachelor’s degree or higher in Mechanical engineering. • 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes. • Excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts. • Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred. • Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques. • Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation. • Proficient in SolidWorks with experience in tool and fixture design. • Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement Nice to Haves: • Lean and/or Six Sigma certifications preferred Employment Type: Full Time Years Experience: 5 - 10 years Bonus/Commission: No
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Manufacturing Engineer
2 weeks ago
Cambridge, United States Quanex Building Products Full timeQuanex is looking for a Manufacturing Engineer to join our talented team located in Cambridge, OH. Responsibilities: The Manufacturing Engineer will be working under limited to general supervision and will be responsible for controlling multiple proj Manufacturing Engineer, Engineer, Manufacturing, Equipment, Project Management, Construction
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Manufacturing Engineer
4 weeks ago
Cambridge, Massachusetts, United States MORSE Corp Full timeJOB SUMMARYAs a Manufacturing Engineer at MORSE, you will participate with the production of new product prototypes as well as manufacturing ramp up existing and new designs. MORSE is passionate about fielding technology to our users. You will play a critical role helping MORSE set up new production lines of novel technologies. You will collaborate closely...
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Manufacturing Engineer
3 weeks ago
Cambridge, Massachusetts, United States MORSE Corp Full timeJOB SUMMARYAs a Manufacturing Engineer at MORSE, you will participate with the production of new product prototypes as well as manufacturing ramp up existing and new designs. MORSE is passionate about fielding technology to our users. You will play a critical role helping MORSE set up new production lines of novel technologies. You will collaborate closely...
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Manufacturing Engineer
6 days ago
Cambridge, Minnesota, United States Nycor Full timeJob Description Job Description Manufacturing Engineer Our client located about an hour north of the Twin Cities metro area is looking to add a Manufacturing Engineer to the team. This position is a brand new opportunity within the organization. Position is a full time direct hire opportunity with very competitive pay, benefits, a thriving environment,...
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Manufacturing Engineer
4 weeks ago
Cambridge, United States Nanobiosym Full timeNanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a...
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Manufacturing Engineer
7 days ago
Cambridge, United States Nanobiosym Full timeNanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a...
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Senior Manufacturing Engineer
6 days ago
Cambridge, Massachusetts, United States Enterprise EQ Full timeHello,Client: Manufacturing IndustryPosition: Medical Device Senior Manufacturing EngineerLocation: Cambridge, MA 02139Duration: 05 Months Contract on W2 basisUS Citizen OR Green Card Holder only Max Pay Rate - $65/hr on W2 - With No Benefits MUST HAVE:Education: Bachelors Degree or higher in Mechanical Engineering.5+ years of experience in Medical Device...
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Senior Manufacturing Engineer
1 week ago
Cambridge, United States Enterprise EQ Full timeJob DescriptionJob DescriptionHello,Client: Manufacturing IndustryPosition: Medical Device Senior Manufacturing EngineerLocation: Cambridge, MA 02139Duration: 05 Months Contract on W2 basisUS Citizen OR Green Card Holder onlyMax Pay Rate - $65/hr on W2 - With No BenefitsMUST HAVE:Education: Bachelors Degree or higher in Mechanical Engineering.5+ years of...
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Manufacturing Engineer
4 weeks ago
Cambridge, United States Nanobiosym Full timeNanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a...
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Manufacturing Engineer
3 weeks ago
Cambridge, United States Nanobiosym Full timeNanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a...
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Engineer: Manufacturing
2 months ago
Cambridge, United States Nanobiosym Full timeJob DescriptionJob DescriptionMust have BSME, MSME preferred. Plastics engineering degree considered. Plastics knowledge with engineering grade resins a must More than 15 years experience Must have medical device experience, disposables preferred. familiar with ISO13485 and 14971 Must have experience with process capability and SPC knowledge of manufacturing...
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Engineer: Manufacturing
3 weeks ago
Cambridge, United States Nanobiosym Full timeJob DescriptionJob DescriptionMust have BSME, MSME preferred. Plastics engineering degree considered. Plastics knowledge with engineering grade resins a must More than 15 years experience Must have medical device experience, disposables preferred. familiar with ISO13485 and 14971 Must have experience with process capability and SPC knowledge of manufacturing...
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Senior Manufacturing Engineer
4 days ago
Cambridge, United States Enterprise EQ Full timeJob DescriptionJob DescriptionHello,Client: Manufacturing IndustryPosition: Medical Device Senior Manufacturing EngineerLocation: Cambridge, MA 02139Duration: 05 Months Contract on W2 basisUS Citizen OR Green Card Holder onlyMax Pay Rate - $65/hr on W2 - With No BenefitsMUST HAVE:Education: Bachelors Degree or higher in Mechanical Engineering.5+ years of...
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Senior Manufacturing Engineer
4 weeks ago
Cambridge, United States Draper Labs Full timeSenior Manufacturing Engineer Job Location US-MA-Cambridge Requisition ID 2024-8080 Overview Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space...
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Senior Manufacturing Engineer
4 weeks ago
Cambridge, United States Draper Labs Full timeSenior Manufacturing EngineerJob Location US-MA-CambridgeRequisition ID 2024-8080OverviewDraper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space...
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Senior Manufacturing Engineer
6 days ago
Cambridge, Massachusetts, United States Draper Labs Full timeSenior Manufacturing EngineerJob Location US-MA-CambridgeRequisition ID OverviewDraper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to...
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Senior Manufacturing Engineer
4 weeks ago
Cambridge, United States The Charles Stark Draper Laboratory Inc Full timeOverview Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide....
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Senior Manufacturing Engineer
4 weeks ago
Cambridge, United States The Charles Stark Draper Laboratory Inc Full timeOverview Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide....
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Senior Manufacturing Engineer
6 days ago
Cambridge, Massachusetts, United States The Charles Stark Draper Laboratory Inc Full timeOverviewDraper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide....
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Senior Manufacturing Engineer
5 days ago
Cambridge, Massachusetts, United States The Charles Stark Draper Laboratory Inc Full timeOverview Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide....
