CathRx is dedicated to advancing the diagnosis and treatment of cardiac arrhythmias through modular catheter technology. Based in Sydney, Australia, CathRx empowers cardiac specialists worldwide with pioneering solutions for both electrophysiology (EP) diagnostics and therapeutic pulsed-field ablation (PFA). Our mission is to improve outcomes for those afflicted by atrial fibrillation by delivering safer, smarter, and more versatile catheter systems, validated by robust clinical data and global regulatory approvals.
We are seeking a motivated and technically skilled Product Development Engineer to join our R&D team. This role is ideal for someone with at least 1 year of experience in medical device development who is eager to contribute across the full product lifecycle, from concept to commercialisation.
Key Responsibilities & Requirements:
* Minimum 1 year of experience in New Product Development (NPD) and New Product Introduction (NPI) within the medical device industry.
* Solid understanding of the product development cycle, including continuous improvement, cost reduction, and efficiency optimisation for existing products.
* Familiarity with Quality Management Systems (QMS) and working under ISO 13485 standards.
* Strong knowledge of medical device manufacturing processes, including:
o Plastic moulding
o Extrusion
o CNC machining
o Laser cutting and welding
o 3D printing
* Proficient in applying Design for Manufacturing (DFM) and Design for Assembly (DFA) principles during both design and production stages.
* Hands-on experience in prototype development using a variety of tools and workshop equipment.
* Ability to collaborate with suppliers, manufacturers, and OEMs to support design and development.
* Skilled in 3D CAD design, particularly with SolidWorks.
* Familiar with design verification and validation (V&V) processes, including drafting validation plans, test protocols, and reports, and conducting compliance testing.
* Strong analytical skills with attention to detail. Experience with DFMEA, PFMEA, and root cause analysis.
* Comfortable working in a multidisciplinary engineering environment and eager to learn new technologies.
* A background in mechanical, electrical or mechatronic engineering is preferred.
Experience supporting clinical-stage medical device development is highly desirable.