Senior Manufacturing Engineer
2 weeks ago
THE COMPANY
Reprieve Cardiovascular ( / currently based in Milford, MA) is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). The company’s Guided Diuretic Therapy is designed to provide clinicians with the ability to precisely tailor a therapy to an individual patient and maximize fluid removal, leading to improved cardiac and renal function and complete decongestion of ADHF patients.
THE ROLE
The Senior Manufacturing Engineer will report to the Director of Operations and will be responsible for designing, developing, and optimizing manufacturing processes for the production of Reprieve’s medical devices, with special focus on custom disposable infusion sets and accessories. This role is essential in driving the company’s growth by ensuring that production processes are efficient, scalable, and aligned with regulatory requirements. You will work closely with cross-functional teams including R&D, Quality, and Regulatory to ensure that our products meet the highest standards of safety, consistency, performance, and regulatory compliance. The successful candidate will be energized by the idea of changing the paradigm of heart failure treatment for patients, working in a fast-paced, early-stage environment, and must be strategic and tactical in their thinking with a hands-on, roll-up their sleeves mindset. Reprieve believes strongly in promoting from within the company wherever possible, and so career growth opportunities will emerge for interested employees as the company expands.
KEY RESPONSIBILITIES
- Process Development: Design, develop, and implement manufacturing processes for both disposable infusion sets and electro-mechanical fluid management instrument to ensure efficiency, scalability, and cost-effectiveness.
- Process Improvement: Continuously monitor and improve existing manufacturing processes to increase efficiency, reduce waste, and ensure product quality.
- Quality Assurance: Collaborate with quality to ensure all manufacturing processes comply with regulatory standards (FDA, ISO 13485, etc.) and maintain product quality and facilitate regulatory audits.
- New Product Introduction: Work closely with R&D during the design phase to ensure manufacturability and participate in the transition from prototype to full-scale production, ensuring timelines, cost, and quality objectives are met.
- Equipment Design & Validation: Design, specify, procure, and validate manufacturing equipment, ensuring it meets production requirements and complies with industry regulations.
- Documentation & Compliance: Create and maintain detailed manufacturing documentation, including process instructions, validations, and change controls, in accordance with Good Manufacturing Practices (GMP).
- Root Cause Analysis: Work with cross functional teams to investigate production issues, perform root cause analysis, and implement corrective actions to prevent recurrence.
- Cost Management: Assist in the identification and implementation of cost-saving initiatives related to materials, labor, and production processes.
- Training & Support: Provide technical support and training to manufacturing staff to ensure the correct operation of equipment and adherence to processes.
REQUIRED QUALIFICATIONS
- Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
- Experience: A minimum of 8-10 years of experience in medical device manufacturing engineering. Experience with disposable medical device manufacturing essential, preferably in disposable tubing sets and accessories.
- Regulatory Knowledge: Strong understanding of FDA regulations, ISO 13485, experience with Design History Files (DHF) or EU MDR Technical Files.
- Technical Skills: Proficiency in CAD software (SolidWorks preferred); experience with Six Sigma tools, statistical analysis software (Minitab, JMP), and ERP systems. Experience with Six Sigma tools a plus.
- Problem-Solving: Demonstrated ability to identify, analyze, and implement solutions for design for manufacture, production, and process issues.
- Communication: Excellent verbal and written communication skills; able to effectively collaborate with cross-functional teams.
- Detail-Oriented: High attention to detail with the ability to manage multiple projects and deadlines.
- Leadership Skills: Ability to lead cross-functional teams and manage complex projects.
PREFFERED QUALIFICATIONS
- Experience with automation systems, robotic integration, industry 4.0 technologies, and process control systems.
- Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
-
Senior Manufacturing Engineer
2 weeks ago
Milford, Massachusetts, United States Reprieve Cardiovascular Full timeJob Title: Senior Manufacturing EngineerReprieve Cardiovascular is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). We are seeking a highly skilled Senior Manufacturing Engineer to join our team and contribute to the design, development, and optimization of our medical...
-
Senior Manufacturing Engineer
2 weeks ago
Milford, Connecticut, United States Reprieve Cardiovascular Full timeJoin Our Team as a Senior Manufacturing EngineerAt Reprieve Cardiovascular, we're revolutionizing the treatment of acute decompensated heart failure with our innovative Guided Diuretic Therapy. As a Senior Manufacturing Engineer, you'll play a critical role in designing, developing, and optimizing manufacturing processes for our medical devices.Key...
-
Manufacturing Engineer
2 weeks ago
Milford, New Hampshire, United States Hitchiner Manufacturing Co., Inc. Full timeAbout Hitchiner Manufacturing Co., Inc.Hitchiner Manufacturing Co., Inc. is a leading supplier of high-volume, complex thin-wall investment castings and fully-finished casting-based subassemblies and components to industry. With a rich history dating back to 1946, our company has established itself as a premier provider of complete-to-print castings, serving...
-
Senior Manufacturing Engineer
3 weeks ago
Milford, United States Reprieve Cardiovascular Full timeTHE COMPANYReprieve Cardiovascular (www.reprievecardio.com / currently based in Milford, MA) is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). The company’s Guided Diuretic Therapy is designed to provide clinicians with the ability to precisely tailor a therapy to an...
-
Senior Manufacturing Engineer
3 weeks ago
Milford, United States Reprieve Cardiovascular Full timeTHE COMPANYReprieve Cardiovascular (www.reprievecardio.com / currently based in Milford, MA) is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). The company’s Guided Diuretic Therapy is designed to provide clinicians with the ability to precisely tailor a therapy to an...
-
Manufacturing Engineer
1 day ago
Windsor Mill, Milford Mill, MD , USA, United States Zentech Manufacturing I Full timeManufacturing Engineer Job DescriptionZentech Manufacturing, Inc. is seeking a skilled Manufacturing Engineer to drive innovation and efficiency in our production processes. As a key member of our team, you will be responsible for developing and implementing repeatable processes for production at scale, refining existing processes for efficiency, and driving...
-
Manufacturing Process Engineer
2 days ago
Windsor Mill, Milford Mill, MD , USA, United States Zentech Manufacturing I Full timeManufacturing Engineer Job DescriptionZentech Manufacturing, Inc. is seeking a skilled Manufacturing Engineer to join our team in New Product Integration and Continuous Improvement. As a Manufacturing Engineer, you will work in a fast-paced production environment with advanced manufacturing processes serving customers in diverse fields, including Defense,...
-
Manufacturing Engineering Technician
2 months ago
Milford, Delaware, United States Baltimore Aircoil Company Full timeJob OverviewPOSITION OBJECTIVEThe Manufacturing Engineering Technician plays a vital role within the Regional Manufacturing Engineering Team. This position is tasked with implementing both regional and global engineering initiatives, providing support to operations teams, ensuring maintenance reliability, and driving continuous improvement and safety...
-
Manufacturing Engineer Tech
3 weeks ago
Milford, United States Baltimore Aircoil Full timePOSITION PURPOSE The Manufacturing Engineer Technician will be a key member of the Regional Manufacturing Engineering Team. This position will be responsible for executing regional and global engineering projects, operations team support, maintenance reliability support, continuous improvement projects, safety projects and daily tasks associated with...
-
Foundry Process Engineer II
3 weeks ago
Milford, Connecticut, United States Hitchiner Manufacturing Co., Inc. Full timeAbout Hitchiner Manufacturing Co., Inc.Hitchiner Manufacturing Co., Inc. is a leading supplier of high-volume, complex thin-wall investment castings and fully-finished casting-based subassemblies and components to industry. With over 75 years of experience, we have established ourselves as a premier partner for companies in the automotive, aerospace, and...
-
Coatings Manufacturing Engineer
1 month ago
Milford, United States 180 Engineering Full timeManufacturing Engineer (Direct Hire)Milford, MIJob Requisition: 7209Description for Manufacturing Engineer:The Manufacturing Engineer is responsible for understanding, defining, documenting, and optimizing processes and process parameters for product as well as ensuring manufacturing equipment complies with safety standards. Manufacturing Engineer will work...
-
Senior Reliability Engineer
4 hours ago
Milford, Connecticut, United States Perdue Full timeJob Title: Senior Maintenance Reliability EngineerPerdue Foods, a leading company in the food industry, is seeking a highly skilled Senior Maintenance Reliability Engineer to join our team. As a key member of our operations team, you will play a critical role in ensuring the reliability and efficiency of our manufacturing processes.Job Summary:The Senior...
-
Manufacturing Engineer
2 weeks ago
Milford, United States Nesco Resource Full timeNesco Resource is looking for a Manufacturing Engineer for our client in the New Haven, CT This in-person role is the perfect opportunity for individuals in the industry looking to develop their skill sets alongside an organization that has been around for over 60 years! Our client designs, develops, and manufactures high-reliability glass to metal hermetic...
-
Senior Reliability Engineer
3 weeks ago
Milford, Connecticut, United States Perdue Full timeJob Title: Senior Maintenance Reliability EngineerPerdue Foods, a leading provider of premium proteins, is seeking a highly skilled Senior Maintenance Reliability Engineer to join our team. As a key member of our maintenance organization, you will play a critical role in ensuring the reliability and efficiency of our manufacturing processes.Job Summary:The...
-
Manufacturing Engineer Technician
1 day ago
Milford, Delaware, United States Baltimore Aircoil Full timeJob SummaryThe Manufacturing Engineer Technician will be a key member of the Regional Manufacturing Engineering Team at Baltimore Aircoil. This role will be responsible for executing regional and global engineering projects, operations team support, maintenance reliability support, continuous improvement projects, safety projects, and daily tasks associated...
-
Manufacturing Engineer Technician
1 week ago
Milford, Delaware, United States Baltimore Aircoil Company Full timeJob SummaryThe Baltimore Aircoil Company is seeking a highly skilled Manufacturing Engineer Technician to join our Regional Manufacturing Engineering Team. As a key member of the team, you will be responsible for executing regional and global engineering projects, supporting operations, maintenance reliability, and continuous improvement initiatives.Key...
-
Welding Engineer
2 weeks ago
Milford, New Hampshire, United States Hitchiner Manufacturing Co., Inc. Full timeJob DescriptionHitchiner Manufacturing Co., Inc. is seeking a highly skilled Welding Engineer to join our team. As a key member of our manufacturing team, you will be responsible for ensuring the highest quality of our products.Key Responsibilities:Review and prepare welding and process instructions, standards, and specifications for complex castings.Manage...
-
Manufacturing Production Specialist
2 days ago
Milford, New Hampshire, United States Hitchiner Manufacturing Co., Inc. Full timeAbout Hitchiner Manufacturing Co., Inc.Hitchiner Manufacturing Co., Inc. is a premier supplier of complete-to-print, high-volume, complex thin-wall investment castings and fully-finished casting-based subassemblies and components to industry. Founded in 1946 and headquartered in Milford, New Hampshire (USA), we lead the industry in volume production, reduced...
-
Senior Maintenance Reliability Engineer
3 weeks ago
Milford, Delaware, United States Perdue Farms Full timeJob Title: Senior Maintenance Reliability EngineerPerdue Farms, a family-owned company, is seeking a Senior Maintenance Reliability Engineer to lead the implementation, continuous improvement, and sustainability of reliability systems and processes within our manufacturing site.Job SummaryThe successful candidate will be responsible for developing, managing,...
-
Senior Mechanical Design Engineer
2 days ago
Milford, Connecticut, United States Waters Full timeJob Title: Senior Mechanical Design Engineer, ClinicalWe are seeking a highly skilled Senior Mechanical Design Engineer to join our Clinical Systems team at Waters. As a key member of our team, you will be responsible for designing and developing innovative mechanical solutions for our automated sample preparation products.About the Role:Provide technical...