Job Title: Process Development Engineer
This is an exciting opportunity for a skilled engineer to join our team and contribute to the development of innovative medical devices.
Job Description:
We are seeking a highly motivated and experienced engineer to support the development and implementation of manufacturing and assembly processes associated with our pVAD catheter. The successful candidate will work closely with our device development and characterization teams, as well as other development functions and Quality.
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 (e.g. calibration and maintenance) for manufacturing processes,
- Executes process characterisation and validation activities,
- Becomes a technical expert in the assembly and manufacture of our 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.
Required Skills and Qualifications:
- Minimum of three years of medical device development experience,
- 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: o Fixture and equipment design & specification o Validation of processes and process equipment o Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes