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This role will be a part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.
The Quality Engineer (medical device manufacturing) plays a key role in ensuring product and process quality through all phases of development, validation, and production, in compliance with ISO 13485 and FDA regulations. This individual will lead root cause investigations, support design controls, and drive continuous improvement initiatives in a fast-paced, innovation-focused environment.
As the Quality Engineer you will gain hands on experience in medical device development, focusing on manual testing, design controls, sterilization, and transit testing. You will collaborate closely with mechanical engineers and cross functional teams to ensure compliance with FDA regulations and ISO 13485 standards.
The Senior Advanced Manufacturing Engineer will work on a team that supports the development of new medical devices and improvements on exciting products. In this role, you will work on a variety of engineering tasks including working on product designs, managing complex projects, developing validation protocols and test methods, and working on continuous improvement initiatives.
The Project Engineer is a key driver of innovative medical device projects, leading development and manufacturing efforts from concept to launch-delivering results on time and in compliance with FDA and ISO 13485 standards.
The Quality Manager, medical device manufacturing, will lead the maintenance and continuous improvement of the quality management system to ensure compliance with regulatory standards and internal requirements at our Marlborough facility. They will oversee supplier quality, incoming inspection, and production support to drive consistency in product and process quality across the organization.
As the Development Engineer, you will lead the design and development of innovative catheter-based medical devices. You'll refine product concepts, create detailed CAD designs, and prototype new solutions. Collaborating with cross-functional teams, you will drive in-vivo and in-vitro study protocols, and ensure manufacturing processes meet the highest quality standards. This role offers the chance to make a significant impact in the medical device industry while advancing cutting-edge healthcare solutions.
This Quality Manager role oversees the quality management system, ensuring compliance with global regulatory standards and driving continuous improvement across manufacturing and operations. It's a high-impact position ideal for someone passionate about quality, innovation, and making a real difference in the medical device industry.
This Quality Manager role requires ensuring cGMP and ISO 13485 compliance, managing quality systems, handling regulatory processes such as CAPA and recalls, and securing successful audits. The position also encompasses continuous improvement initiatives, data analysis, team leadership, and supplier quality management to assure the dependability and uniformity of medical devices.
The Senior Quality Assurance Engineer will lead both quality and design assurance activities. This role involves developing and implementing quality management systems, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to support product development and manufacturing processes.
My client, based in Springfield, MA, is seeking a detail-oriented, self-motivated individual to manage multiple projects at various stages. As a project lead, you'll oversee all controls engineering tasks to ensure successful project completion. My client looks for dedicated individuals passionate about precision, innovation, and continuous improvement
The Quality Manager will be responsible for ensuring products meet rigorous quality standards while driving operational efficiency and implementing technical solutions to enhance reliability and performance. They will focus on continuous improvement to guarantee timely delivery of high-quality products that meet customer expectations.
The Quality Engineer develops and implements quality policies to ensure ISO 13485 compliance, leads investigations into manufacturing issues, non-conformances, and customer complaints through CAPA initiatives. They also create validation protocols, oversee process and product qualifications, and analyze data, feedback, and quality costs to drive continuous improvement
Oversee product quality from development to delivery, working closely with customers, while supporting and maintaining the QMS (ISO 13485) to ensure compliance with industry standards. Lead new product introductions, interpret GD&T drawings, develop measurement methods, program vision systems (OGP Smart Scope), and utilize SPC, DOE, and Gage R&R for continuous process improvement and root cause analysis.
The Quality Engineer, Medical Device Manufacturing, will lead efforts to ensure product quality and compliance by developing and implementing quality processes, investigating non-conformities, and driving continuous improvement initiatives. This role requires a hands-on approach, working closely with manufacturing, engineering, customers, and suppliers to uphold the company's quality standards.
The Senior Tooling Engineer will serve as the technical expert in injection molding, leading a small team of skilled engineers. This role will work closely with Business Development to drive new business opportunities and oversee all new projects at the Massachusetts facility. The position reports directly to the General Manager.
This Product Development Quality Engineer role involves ensuring adherence to strict quality and regulatory standards throughout product and process lifecycles, leading quality initiatives, and driving continuous improvement. Responsibilities also include technical leadership, mentorship, and collaboration with internal and external stakeholders to guarantee the development of high-quality, compliant medical devices
The Design Quality Engineer is responsible for ensuring that medical device components meet customer and regulatory requirements through root cause analysis, corrective actions, and continuous improvement initiatives. The role involves close collaboration with engineering, production, and quality teams to support new product introductions and maintain consistent product quality.
My client is seeking a talented and innovative Advanced Manufacturing Engineer to join their dedicated team in the medical device manufacturing industry. The ideal candidate will be a proactive problem solver, with a knack for identifying areas of improvement in the manufacturing process.
Are you passionate about making a positive impact on people's lives through cutting-edge medical devices? In this Senior Manufacturing Engineer role you will be responsible for leading manufacturing process development, optimization, and validation activities for medical device products.
The Senior Manufacturing Engineer will be an essential piece in the development of over 90 different products. You will have the opportunity to be hands on development through the manufacturing phase.
The Quality Manager, medical device manufacturing, will ensure products meet strict quality standards while driving continuous improvement to enhance reliability and performance. This role focuses on optimizing operational efficiency and implementing technical solutions to deliver high-quality products on time at our Bedford, MA facility.
As the Senior Manufacturing Engineer, you will lead the development and improvement of medical devices, working on new products, product enhancements, and technology transfers. You'll manage complex tasks such as prototyping, testing, data analysis, and project management while ensuring products meet performance specifications. You will collaborate with surgeons, gather feedback, and oversee the procurement of materials. Your role will involve using engineering software, developing test methods, and recommending cost improvements to enhance product quality and efficiency.
The R&D Engineer will play a crucial role in designing and advancing catheter technology for major healthcare and medical device companies nationwide.
My client is seeking a new addition to lead their Field Service Engineering and Technical Services Team's Globally. This individual will develop and oversee a comprehensive service strategy to strategically align with my client's business goals and innovations. They will have ownership over customer bases in North America, EMEA, and other regions. This will be a terrific opportunity to make an impact through strategic thinking and coaching/development.
The Manufacturing Engineer will be responsible for current products currently on the market while growing a team of manufacturing and process engineers along the way. The team is seeking to add 10 new talented individuals to their production, supply chain and quality team throughout 2025.
As a Quality Manager it involves hands-on laboratory work, primarily focusing on cell culture and flow cytometry, within a team dedicated to developing and validating new assays. The position requires meticulous documentation and adherence to established protocols, contributing directly to the advancement of cell analysis technologies.
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