Job Title: Process Development Engineer
Company:
Our client is a medical device company developing innovative heart support devices.
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Job Description:
As a Process Development Engineer, you will support the development and implementation of manufacturing processes for our pVAD catheter. Your key responsibilities include design feedback and input, working with suppliers of catheter components, and collaborating with device development and characterization teams.
Key Responsibilities:
* Develops manufacturing processes, materials, and methods as part of the product development team.
* Designs, specifies, procures, and qualifies process fixtures and equipment.
* Develops Work Instructions and other supporting documentation for manufacturing processes.
* Executes process characterization and validation activities.
* Becomes a technical expert in the assembly and manufacture of our products, providing technical guidance to other team members.
* Supports cleanroom setup, fit-out & validation.
* Evaluates relevant process & manufacturing technologies and strategically identifies opportunities to implement them.
* Executes project plans, tasks, and deliverables. Manages time to meet project deadlines.
* Uses structured problem-solving techniques and statistical methods for data-driven analysis and decisions.
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Requirements:
* Minimum of three years of medical device development experience.
* A primary or Master's Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing, or biomedical engineering.
* Experience in fabrication and manufacture of catheter-based medical devices; large calibre delivery systems are an advantage.
* Product and process development, and new product introduction skills in medical devices are a must.
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This is an exciting opportunity to join a dynamic team driving innovation in the medical device industry.