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Summary
About the Role
About You
- Bachelor’s degree in Engineering or related field.
- Minimum of six (6) years of experience in Manufacturing, Quality Engineering/Quality Control and Operations, R&D, design control, risk analysis, design verification, design validation, process validation, test method validation and data analysis.
- Demonstrated command and knowledge of FDA and ISO medical device quality system requirements.
- Proven experience in statistical analysis (statistical analysis tools).
- Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc.).
- Solid written and verbal communication skills.
- Ability to provide technical leadership in process validation, test method validation, data analysis, design control, risk analysis, design verification, and design validation.
- Strong knowledge of medical device design control process.
- Ability to understand the technology related to MicroVention’s products.
- Strong knowledge of medical product quality assurance.
- Strong mathematics skills with working knowledge of statistical tools.
A global leader in neurovascular innovation, MicroVention is now Terumo Neuro. This name change signifies a new chapter in the company’s evolution while maintaining its unwavering commitment to the creation and commercialization of groundbreaking innovations in neurovascular care. We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in California, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California, and San José, Costa Rica.