Job Title: Device Development Specialist
Description:
The company is developing a new and innovative heart support device to stabilize patients in acute heart failure or undergoing high-risk coronary procedures. The objective is to provide interventional cardiologists with a more effective and less invasive device.
The successful candidate will have hands-on knowledge and experience in both the development of cardiovascular devices and the processes required to manufacture them.
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 characterisation and validation activities.
* Becomes a technical expert in the assembly and manufacture of products, and provides technical guidance to other team members.
* Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
* Works with internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meets design input.
* 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 Skills.
Required Qualifications:
* Minimum of three years of medical device development experience, and have either 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; experience in large calibre delivery systems is an advantage.
* Product and process development, and new product introduction skills in medical devices are a must. In particular: Fixture and equipment design & specification, Validation of processes and process equipment, Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes.
What We Offer:
We offer a challenging and rewarding role that will allow you to develop your skills and expertise in medical device development.
About Us:
We are a medical device company dedicated to developing innovative solutions for heart support devices.
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