Senior R&D Engineer
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.
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