Job Summary:
Senior R&D Engineer required to lead the design verification testing in a GxP environment. The ideal candidate will have a strong technical background in mechanical or biomedical engineering and experience working with medical devices, particularly cardiovascular or neurovascular implants.
Responsibilities
* Plan and execute Design Verification testing in a GxP environment.
* Perform data analysis and test reporting.
* Collaborate in defining evaluation and testing strategy for product/process changes.
* Create and/or update component specifications.
* Investigate product complaints and analyze returned devices.
* Contribute to the project team to deliver key objectives, meeting performance, time, and cost targets.
* Write procedures, protocols, specifications, and reports.
* Understand physician (user) techniques and clinical needs (disease state) 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 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.