Job Title: Invasive Medical Device Engineer
">"Overview
The role involves supporting the development and integration of hardware/software systems associated with Single Use Devices (SUD) to ensure compliance with regulatory and safety standards. This position will be a key contributor to innovation, intellectual property development, and new technologies for enabling safe, effective, and differentiated therapy delivery systems.
Key Responsibilities:
1. Develop verification and validation plans, protocols, and reports
2. Integration of design requirements into the system (i.e. Risk management, Design inputs, Design Outputs, etc.)
3. Ensure compliance to industry and international standards
4. Understanding of catheter design and delivery system assembly
5. Communicate technical updates at weekly team meetings to project leaders and senior stakeholders
6. Perform troubleshooting on observations related to design, material or process
7. Develop a deep understanding of test methods including electronic test failures and therapeutic performance to guide product development and scientific knowledge
8. Invent/create concepts, designs, and submit idea disclosures
9. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all related quality processes and procedures
10. Interface with vendors and physicians where projects require
Qualifications:
* Level 8 Honours Degree in a relevant Technical Discipline, preferably Mechanical or Biomedical Engineering
* 3+ years relevant experience
* Strong data analysis & engineering skills
* Excellent organizational, communication, and collaboration skills
* Excellent analytical and problem-solving skills