| Prototype, assemble and iterate design concepts using rapid-cycle feedback. Execute design verification and validation testing, test method development/validation and process development/validation with minimal supervision. Complete documentation of data (test methods) and prepare written reports (drawings, protocols, reports, manufacturing instructions) that contribute to the Design History File while assuring accuracy and completeness. Drive root-cause analysis and continuous improvement of design and build processes. Support preclinical (animal) studies. Deliver timely project updates and manage requirements efficiently. Contribute to IP generation, patent filings and technical publications. Education: BS in Mechanical Engineering required. Advanced degree is a plus. Experience: 5-7 years in the medical device R&D, preferably with implantable, vascular or neurovascular preferred) Demonstrated expertise with miniaturized surgical devices and implants in the vascular space Proven experience participating in and supporting animal studies Skills: Strong interpersonal, organizational and communication skills Hands-on, results-oriented team player with the ability to thrive in a lean startup environment Hands-on experience with Nitinol component design Proven ability to deliver results in deadline-driven, dynamic settings High proficiency in SolidWorks is required •Statistical analysis (sample plans, reliability calculations) knowledge Proficient with Microsoft Office applications |
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