Job Description
Job Description
Summary :
Use engineering knowledge to design, develop, verify and validate product designs in support of company's strategic plan. Contribute as part of a cross-functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing.
Principal Tasks & Responsibilities :
- 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.
Qualifications : 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 spaceProven experience participating in and supporting animal studiesSkills :
Strong interpersonal, organizational and communication skills (written and oral)Hands-on, results-oriented team player with the ability to thrive in a lean startup environmentProven ability to deliver results in deadline-driven, dynamic settingsHigh proficiency in SolidWorks is requiredStatistical analysis (sample plans, reliability calculations) knowledgeProficient with Microsoft Office applications