R&D Engineer

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.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, protocols, and reports to support design control activities.
• Accurately document data and prepare written reports for inclusion in the Design History File.
• Participate in and contribute to periodic team updates and actively support any project change requests.
• Troubleshoot assembly process issues and train R&D technicians on product assembly.
• Contribute to IP generation, patent filings and technical publications.
• Drive root-cause analysis and continuous improvement of design and build processes.

Qualifications:

Education:

• BS in Mechanical Engineering required. Advanced degree is a plus.

Experience:

• 4-6 years industry experience with Class II or Class III medical device
• 3+ years in neurovascular product development, with microcatheter-based technologies and accessories
• Participated and supported animal studies
• Familiar with neurovasculature and regulatory (DV) requirements

Skills:

• Strong interpersonal, organizational and communication skills (written and oral)
• Hands-on, adaptable team player with positive, goal-focused mindset
• Demonstrated ability to deliver results in a dynamic, deadline-driven environment
• Statistical analysis (sample plans, reliability calculations) knowledge
• High proficiency in SolidWorks required
• Proficient with Microsoft Office applications