About the Role:
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The company is developing a new medical device to support the heart. This innovative device will provide interventional cardiologists with a more effective and less invasive solution for patients in acute heart failure or undergoing high-risk coronary procedures.
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As a Process Development Engineer, you will play a key role in supporting the development and implementation of manufacturing and assembly processes associated with the pVAD catheter. You will work closely with counterparts responsible for device development and characterization, other development functions, and Quality.
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Responsibilities include:
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* Developing manufacturing processes, materials, and methods as part of the product development team
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* Designing, specifying, procuring and qualifying process fixtures and equipment
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* Developing Work Instructions and other supporting documentation for manufacturing processes
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* Executing process characterisation and validation activities
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* Becoming a technical expert in the assembly and manufacture of products
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* Providing technical guidance to other team members
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* Maintaining compliance to all quality requirements
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* Working with internal cross-functional teams and contract manufacturers or design firms to ensure system design meets design input
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* Supporting cleanroom setup, fit-out & validation
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* Evaluating relevant process & manufacturing technologies and identifying opportunities to implement them
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* Executing project plans, tasks and deliverables
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Requirements:
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To be successful in this role, you will need:
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* A minimum of three years of medical device development experience, and either a primary or Master's Degree in a relevant engineering discipline
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* Experience in fabrication and manufacture of catheter based medical devices; large calibre delivery systems are an advantage
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* Product and process development, and new product introduction skills in medical devices
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About Us:
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We are a leading medical device company dedicated to developing innovative solutions for heart support devices. Our goal is to provide interventional cardiologists with a more effective and less invasive solution for patients in acute heart failure or undergoing high-risk coronary procedures.
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We offer a dynamic and enthusiastic team environment with diverse backgrounds and expertise located in the Netherlands and Ireland.
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Join us in shaping the future of heart support devices and making a meaningful impact on patient lives.