Senior Research And Development Engineer, Medical Device
Location: Aliso Viejo, California, United States
Our new Medical Device client has brought life-changing relief to millions of patients suffering from spinal issues and has a 98% success rate with their product. The company was started in 2005 and continues to grow with strong financial stability. SSI is partnering to help with multiple R&D/NPD positions including a Senior R&D Engineer position who will apply design and development experience toward enhancing existing products and introducing new products, perform R&D engineering project-based assignments, design and validate fixturing for manufacturing processes and assembly, and drive quality and manufacturing improvements. This company has a great culture and some unique additional benefits, as well.
The Right Talent:
Bachelor’s Degree in Engineering
5+ years’ relevant experience in the medical device industry OR advanced degree with minimum of 3 years’ experience in the medical device industry
Experience with Class II or Class III devices Experience writing and performing Design Verification and Validation
Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR 820, ISO 14971:2012, IEC 60601, ISO 13485, EN 62304, and IEC 62366) to Design Controls
Strong understanding of quality systems, regulatory requirements, development and manufacturing processes.
This is a hybrid position with 3 days on-site weekly
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