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 space
• Proven experience participating in and supporting animal studies

Skills:

• Strong interpersonal, organizational and communication skills (written and oral)
• Hands-on, results-oriented team player with the ability to thrive in a lean startup environment
• 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