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catheter-based ablative therapies such as Renal Denervation (RDN)which is an exciting growth driver for BSC.
This R&D role will be a key part of the development and integration of hardware/software systems associated with Single Use Devicesensuring compliance with regulatory and safety standards. Also this role is a key contributor to innovation, intellectual property development and new technologies for enabling safe, effective, and differentiated therapy delivery systems.
Key Responsibilities:
Develop verification and validation plans, protocols, and reports
Integration of design requirements into the BSC system (i.e. Risk management, Design inputs, Design Outputs etc.)
Ensure compliance to industry and international standards.
Understanding of Catheter design and delivery system assembly
Communicates technical updates at weekly team meetings to project leaders and senior stakeholders
Performs troubleshooting on observations related to design, material or process.
Develop a deep understanding of test methods including electronic test failures and therapeutic performance to guide product development and scientific knowledge
Invents/creates concepts, designs and submits idea disclosures
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Interfaces with vendors and physicians where projects require
Works independently to plan and schedule own activities necessary to meet timelines.
Create a strong team culture around high expectations & high performance
Designs, procures and fabricates tooling and fixtures
Required:
Level 8 Honours Degree in a relevant Technical Discipline, preferably Mechanical or Biomedical Engineering
Strong data analysis & engineering skills
Excellent organizational, communication and collaboration skills
Excellent analytical and problem-solving skills
Ability to draw conclusions and make recommendations based on technical inputs from multiple sources
Candidates should have a proven track record of working in a fast-paced environment with strong technical capabilities
Capable of handling multiple development aspects of assigned projects
Preferred:
Experience within the Medical Device industry
Worked on catheter-based systems
Excellent organizational, communication and collaboration skills
Solid statistical analysis
Hands-on approach to problem solving
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