Job Description:
">
Our client is a medical device company developing innovative heart support devices for interventional cardiologists. They aim to provide effective and less invasive solutions for patients in acute heart failure or high-risk coronary procedures.
">
The Job Title is Process Development Engineer, responsible for manufacturing and assembly process development, design feedback, and working with suppliers of catheter components. The successful candidate will work closely with the product development team and have hands-on knowledge of cardiovascular device development and manufacturing processes.
">
Key Responsibilities include:
">
* Developing manufacturing processes, materials, and methods using in-house and external development paths
">
* Designing, specifying, procuring, and qualifying process fixtures and equipment
">
* Developing Work Instructions and supporting documentation for manufacturing processes
">
* Executing process characterization and validation activities
">
* Becoming a technical expert in assembly and manufacture of products, providing guidance to other team members
">
* Building Quality into all aspects of work by maintaining compliance to quality requirements
">
* Working with internal cross-functional teams and contract manufacturers or design firms to ensure system design meets design input
">
* Supporting cleanroom setup, fit-out, and validation
">
* Evaluating process and manufacturing technologies, strategically identifying opportunities to implement them
">
* Executing project plans, tasks, and deliverables, managing time to meet project deadlines
">
* Using structured problem-solving techniques and statistical methods for data-driven analysis and decisions
">
">
Required Qualifications include:
">
* Minimum three years of medical device development experience, with 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 an advantage
">
* Product and process development, and new product introduction skills in medical devices essential
">
* Fixture and equipment design, specification, validation of processes and process equipment, and development of Work Instructions and Calibration & Maintenance activities for manufacturing processes required
">
">
Does this sound like your next career move? For more information, please forward your application.
"],