Senior R&D Engineer
As a Senior R&D Engineer at {company}, you will play a crucial role in driving the design, testing, and development of cutting-edge medical devices.
Key Responsibilities:
* Plan and execute Design Verification testing in a GxP environment to ensure the highest standards of quality and safety.
* Perform data analysis and provide detailed test reports to inform product development decisions.
* Collaborate with cross-functional teams to define evaluation and testing strategies for product and process changes.
* Create and/or update component specifications to meet evolving regulatory requirements.
* Investigate product complaints and analyze returned devices to identify areas for improvement.
* Contribute to project teams to deliver key objectives, meeting performance, time, and cost targets.
* Develop and maintain procedures, protocols, specifications, and reports to ensure compliance with industry standards.
* Understand physician techniques and clinical needs, and assist in developing product training materials.
Requirements:
* Honours degree in Mechanical or Biomedical Engineering or equivalent.
* Approximately 8 years of experience in a medical device design or manufacturing environment.
* Prior experience working in the design and testing of stents, stent delivery systems, and neurovascular catheters.
* Knowledge of metals, including Nitinol, Stainless Steel, Platinum, and their applications.
* Working knowledge of Finite Element Analysis (FEA), laser cutting/annealing, and treatments of metallic components.
* Strong hands-on experience with testing of stents and neurovascular devices (TMV and Gage R&R knowledge).
* Strong technical leadership in new product development, with an expert understanding of disease states and creative product solutions.
* Data review and statistical methods skills (e.g., Minitab).
* Experience with medical devices, particularly cardiovascular or neurovascular implants.
* Strong work ethic, creative problem solving, and capable of working on own initiative.