Job Opportunity: Medical Device Development Specialist
We are seeking a skilled and experienced medical device development specialist to join our team. As a key member of our product development group, you will play a crucial role in the design, development, and implementation of manufacturing processes associated with our innovative heart support devices.
Key Responsibilities:
* Develop manufacturing processes, materials, and methods as part of the product development team
* Design, specify, procure, and qualify process fixtures and equipment
* Develop Work Instructions and supporting documentation for manufacturing processes
* Execute process characterisation and validation activities
* Provide technical guidance to other team members on assembly and manufacture of products
* Ensure quality compliance by maintaining adherence to all quality requirements
* Collaborate with internal and external teams to ensure system design, architecture, and verification/validation meet design input
* Support cleanroom setup, fit-out, and validation
* Evaluate process and manufacturing technologies for strategic opportunities
* Manage project plans, tasks, and deliverables to meet project deadlines
Required Qualifications:
* Minimum of three years of medical device development experience
* Relevant engineering degree (e.g., polymer, mechanical, manufacturing, biomedical)
* Experience in fabrication and manufacture of catheter-based medical devices
* Product and process development skills in medical devices