Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

• Lead project teams through novel interventional device development while providing technical oversight, budget and timeline management, and effective customer communication
• Set direction on core technical strategies for development programs
• Mentor junior resources
• Summarize and refine product specifications
• Brainstorm novel therapeutic concepts
• Perform concept refinement and generate detailed CAD design
• Prototype and evaluate catheter-based designs
• Perform engineering calculations, including tolerance analysis
• Develop and maintain drawing packages
• Develop in-vitro test methods, including fixture design and fabrication
• Perform in-vivo and in-vitro study protocol development, execution, reporting
• Develop manufacturing processes and documentation
• Create and maintain design controls documentation
• Generate product risk analyses
• Foster client relationships and provide responsive service in a contract environment
• Adhere to Quality Management System procedures/design controls
• Participate in internal technical or process improvement initiatives
• Prepare proposals, including definition of scope, timeline, and budget
• Other duties as assigned

• A minimum of 5 years experience in medical device development
• Proficiency in MS Office suite and SolidWorks
• Attention to detail and comfort working in a regulated industry
• Ability to present and convey complex engineering ideas to internal stakeholders and external customers
• Ability to create job-related documentation for quality purposes
• Ability to quickly and positively adapt to changing priorities and processes (product of input on multiple projects in customer-driven environment)
• Strong communication and organizational skills
• Ability to work under minimal supervision
• Familiarity with ISO 13485 and 21 CFR

Salary- $95,000-120,000