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The NPI Engineer will be a key player in the development of essential medical device products through design development into manufacturing through the entire product life cycle phase.
The Design Quality Engineer will play a critical role in ensuring that medical devices meet regulatory and quality standards throughout the product development lifecycle. This position involves collaborating with cross-functional teams to identify design risks, implement process improvements, and maintain compliance with ISO and FDA regulations.
The Design Quality Engineer will focus on supporting the development of vascular treatment catheters, with a strong emphasis on mechanical, electrical, and software integration for new product introduction (NPI). They will collaborate with R&D to ensure high-quality design and product development, leveraging their dual EE background to address complex technical challenges at our Southborough, MA facility.
The Senior Design Quality Engineer ensures the highest quality standards for advanced micromanufactured components used in medical devices, focusing on compliance, process improvement, and defect prevention. The role involves collaborating with cross-functional teams to develop and validate robust quality systems, driving innovation in medical device manufacturing.
The Quality Engineer ensures that products meet strict regulatory standards and quality requirements throughout the design, development, and production phases. They analyze processes, conduct risk assessments, and implement quality controls to maintain compliance with standards like ISO 13485 and FDA regulations.
The Automation Engineer will be responsible for automating, developing and implementing specific practices throughout the project time line through development and into manufacturing.
The Principal Powder Processing Engineer will design and implement key components for battery manufacturing, focusing on dry bulk powder handling and mixing systems. This role involves optimizing processes and collaborating with internal teams and suppliers to ensure project success in a fast-paced start-up environment.
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