- Terumo Neuro (Aliso Viejo, CA)
- …Responsible for preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international ... regulatory agency requirements for Neurovascular and Peripheral devices. Job duties: + As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. + Depending on… more
- Terumo Neuro (Aliso Viejo, CA)
- …Leads all maintenance functions of production equipment in the assigned area. Work includes routine inspection and repair or replacement of defective or faulty parts ... on machines and related equipment. All work to be performed in such a matter to ensure good workmanship with minimum delay. This position is expected to take a proactive role in supporting the mfg team, provide internal customer support, and build a high level… more
- Terumo Neuro (Aliso Viejo, CA)
- …**INNOVATION STARTS WITH YOU** Are you interested in working for an organization that is making a difference in people's lives every day? We're a medical devices ... company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products… more
- Terumo Neuro (Aliso Viejo, CA)
- …Act as a strategic collaborator across Medical Affairs and cross-functional teams, helping to translate complex clinical data into actionable insights. Support the ... development of evidence packages that inform regulatory strategies, publications, and broader business objectives. Contribute to the generation of high-quality, scientifically sound outputs by applying advanced analytical methods, including machine learning… more
- Terumo Neuro (Aliso Viejo, CA)
- …Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, ... writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts,… more
- Terumo Neuro (Aliso Viejo, CA)
- …The Associate Product Manager executes strategic marketing activities and contributes to the development of a fully global marketing strategy for their product ... line(s), establishing successful relationships and working effectively with physicians, healthcare professionals, global sales and distribution teams, and internal cross-functional stakeholders. Executes short and long-term marketing strategies and tactics for… more
- Terumo Neuro (Aliso Viejo, CA)
- …Manage the front desk/reception area for multiple buildings in the complex (not simultaneously), while performing general/specialized Office Services and Human ... Resources support functions. General clerical and administrative support to include data entry, report generation, answering incoming calls, filing, and database administration. Responsible for day-to-day administrative tasks including providing relevant… more
- Terumo Neuro (Aliso Viejo, CA)
- …Create, lead, and oversee the Project Management Office (PMO). Requires strong leadership, exceptional project management skills, and a deep understanding of the ... management and execution to ensure successful project delivery across the organization. Job duties: Leadership and Strategy + Develop and execute a comprehensive project management strategy, aligned with the organization's goals and objectives. + Provide… more
- Terumo Neuro (Aliso Viejo, CA)
- …Support clinical safety aspects of MicroVention clinical studies. Job duties: + Provide all required clinical safety support to assigned clinical studies, including ... study safety documentation development, adverse events (AE) review, safety investigations, and startup/management of independent safety committees/ adjudicators. + Draft, review, and provide input to the clinical safety components of clinical study protocols,… more
- Terumo Neuro (Aliso Viejo, CA)
- …Performs the assembly or sub-assembly of medical device and products in a more senior position under limited supervision from line leaders and supervisors in ... accordance with manufacturing documents and verbal instructions. In addition this position will have responsibility for the finished quality of the product in accordance with the quality system as set by the company. * Using written and verbal instruction to… more