Job Title:
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Process Development Engineer
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Company Overview:
We are a leading medical device company that specializes in developing innovative heart support devices for interventional cardiologists.
Our goal is to create more effective and less invasive solutions to overcome the limitations of current assist devices.
Founded in 2018, we have an enthusiastic team with diverse backgrounds and expertise.
Job Description:
As a Process Development Engineer, you will play a key role in supporting the development and implementation of manufacturing processes for our pVAD catheter.
You will work closely with our device development and characterization teams, as well as other development functions and Quality to realize the full potential of the product.
The successful candidate will possess entrepreneurial spirit, persistence, and resourcefulness to succeed in a start-up environment.
They will also have hands-on knowledge and experience in cardiovascular device development and manufacturing processes.
Key Responsibilities:
* Develops manufacturing processes, materials, and methods using in-house and external development paths
* Designs, specifies, procures, and qualifies process fixtures and equipment
* Develops Work Instructions and supporting documentation for manufacturing processes
* Executes process characterisation and validation activities
* Becomes a technical expert in assembly and manufacture of products, providing guidance to other team members
* Builds Quality into all aspects of work by maintaining compliance to quality requirements
* Works with internal cross-functional teams and contract manufacturers or design firms to ensure system design meets design input
* Supports cleanroom setup, fit-out & validation
* Evaluates process & manufacturing technologies, strategically identifying opportunities to implement them
* Executes project plans, tasks, and deliverables, managing time to meet project deadlines
* Uses structured problem-solving techniques and statistical methods for data-driven analysis and decisions
Required Qualifications:
* Minimum of three years of medical device development experience with a primary or Master's Degree in a relevant engineering discipline
* 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 essential, particularly fixture and equipment design & specification, validation of processes and process equipment, and development of Work Instructions and Calibration & Maintenance activities for manufacturing processes
Additional Information:
The salary range for this position is €80,000 - €120,000 per year, depending on experience.
The currency is Euro (EUR).