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Formlabs
Somerville, MA, United States
Senior Advanced Manufacturing Engineer Department: Manufacturing Location: Somerville, MA To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring groundbreaking professional 3D printers to the desktop of every designer, engineer, researcher, and artist in the world. Our passion is designing and building po
Job Source: FormlabsBRIOHEALTH SOLUTIONS INC
Boston, MA, United States
Job Description Job Description BrioHealth Solutions Inc., Inc. is seeking an experienced and driven Advanced Manufacturing Engineer to join our dynamic team. As an Advanced Manufacturing Engineer, you will play a pivotal role in the transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulato
Job Source: BRIOHEALTH SOLUTIONS INCLocus Robotics
Wilmington, MA, United States
Locus Robotics is a leader in the rapidly growing eCommerce order fulfillment optimization space. Our solution helps warehouse owners attain 2-3X efficiency improvement over cart-picking operations, by empowering pickers to work collaboratively with our robots. All this is accomplished while integrating with the operator’s Warehouse Management Syst
Job Source: Locus RoboticsMarkforged
Waltham, MA, United States
As a Manufacturing Engineer on the Operations Engineering team, you will drive Design for Manufacture (DFM) & Design for Assembly (DFA) initiatives during the development and launch phases for NPI projects and other critical aspects throughout the phase gate process. You will report to the Operations Implementation Engineering Manager, building a
Job Source: MarkforgedDSJ Global
Boston, MA, United States
Senior Manufacturing Engineer We are seeking an individual to establish and maintain a new manufacturing process line using cutting-edge technology, including automation, 3-D printing, and robotics. The goal is to identify and implement improvement opportunities, applying lean manufacturing methodologies to ensure simpler, faster, cost-effective,
Job Source: DSJ GlobalRaytheon
Boston
*Date Posted:* 2024-07-01*Country:* United States of America*Location:* CA602: Goleta (RVS) Bldg B01 6825 Cortona Drive Building B01, Goleta, CA, 93117 USA*Position Role Type:* Onsite*Posting Title: Senior Manufacturing Engineer (Onsite)* At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nati
Job Source: RaytheonHome Market Foods, Inc.
Norwood, MA, United States
Join our vibrant and rapidly expanding organization at the forefront of innovation in the manufacturing industry. We're seeking a Sr. Mechanical Engineer to revolutionize existing workflows, elevate equipment standards, and drive forward-thinking design initiatives. As a pivotal member of our dynamic Process Engineering Department, you'll have th
Job Source: Home Market Foods, Inc.Formlabs
Somerville, MA, United States
To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring groundbreaking professional 3D printers to the desktop of every designer, engineer, researcher, and artist in the world. Our passion is designing and building powerful 3D printing tools. Our manufacturing team is responsible for research and development o
Job Source: FormlabsBoston, MA, United States
Job Description Job Description Senior Advanced Manufacturing Engineer
Job DescriptionBrioHealth Solutions Inc., Inc. is seeking an experienced and driven Senior Advanced Manufacturing Engineer to join our dynamic team. As a Senior Advanced Manufacturing Engineer, you will be an integral member of the project team and lead the design and transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulatory goals are met. Specifically, you will be responsible for Design for Excellence and process development. Your expertise will contribute to the organization's operational efficiency and overall success.Responsibilities Design Transfer: As a member of the project team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products into manufacturing.
You will develop and implement manufacturing plans to accomplish a robust design transfer from initial concept to full production to support new products, product changes and enhancements.
You will design and develop manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
You will be responsible for creating and executing all validation plans, protocols, and reports (PC/IQ/OQ/PQ).
You will be responsible for the product Cost of Goods Sold (COGS) and drive the project team toward cost effective solutions during concept and design selection.
As part of the project team, you will be responsible for leading the pFMEA process, DFM/DFA, risk analysis and process control strategies.
Process Support and Improvement: Achieve Operations deliverables by working with Manufacturing Engineering and Quality to investigate production issues, identify failure modes to improve production throughput and yields.
You must possess a broad understanding of current process technologies, bio/med device assembly methodologies, commercial fabrication techniques, creating and maintaining specialized environments, etc.
You will research new manufacturing technologies and operational methodologies to ensure our products remain innovative and cutting edge.
Provide training materials and training for manufacturing personnel for newly developed processes as needed.
You will quantify current and future manufacturing requirements, perform capacity analyses, and implement capacity scale-up as required.
Supplier Management: Interface with outside vendors to address capacity or quality issues with components, materials, and subassemblies.
Build and maintain strong relationships with manufacturing process and equipment suppliers. Identify alternative suppliers as needed.
Work with Procurement Leaders at BrioHealth Solutions to identify alternative suppliers as needed.
Cross-functional Collaboration:
Apply persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to meet market and revenue requirements.
Work closely with various departments, including R&D, quality and manufacturing, to understand their needs.
Other: Accept additional responsibilities as assigned by manager or Operations management.
Mentor and develop junior level Advanced Manufacturing Engineers toward professional growth.
Identify technical risks, resource problems and work arounds.
Development of intellectual property is required.
Requirements Bachelor’s degree in Manufacturing, Electrical, Mechanical Engineering or other engineering discipline. Master’s degree is a plus.
Minimum of 7 years of experience in product or process development.
Medical device, pharmaceutical, and biotechnology work experience is highly preferred.
Experience in an FDA/ISO regulated environment (eq. ISO 9000, ISO 13485, FDA 21 CFR, EU MDR) is preferred.
Proven track record of successfully managing the transfer of complex development projects from R&D to Manufacturing.
Experience creating documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, CAPAs, NCMRs, regulatory submissions) is preferred.
Excellent project management, communication and interpersonal skills.
Proficiency in design software (SolidWorks) and tools.
Proficient in Microsoft Office 365 applications and tools.
Strong organizational skills and attention to detail.
Leadership skills and the ability to mentor and guide junior team members.
About BrioHealth Solutions Inc BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.
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Email Alert for Senior Advanced Manufacturing Engineer jobs in Boston, MA, United States
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