Job Title: Process Development Specialist
Job Description:
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Overview:
The role of the Process Development Specialist involves supporting the development and implementation of manufacturing and assembly processes associated with cardiovascular devices. This includes working closely with colleagues responsible for device development and characterization, other development functions, and Quality to realize full potential.
Key Responsibilities:
* Develops manufacturing processes, materials, and methods as part of the product development team using in-house and external development paths.
* 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.
Requirements:
* 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.
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