Product Development Engineer

About the role

The Product Development Engineer will lead design and development projects for Intuitive training models. This position requires an extremely motivated and self-driven individual with a high capacity to learn, analyze and address problems in a fast-paced product development environment. It requires a proactive mindset, a strong understanding of the use cases for the models, and collaboration skills to address unmet needs and identify practical, cost-effective design solutions.

Responsibilities

• Lead product development projects for model iterations and design changes for improved user experience, training effectiveness and realism, manufacturability, reliability, and cost.
• Support new model introduction projects.
• Resolve unmet model needs and engineering challenges through rapid prototyping, design and testing, while collaborating with researchers, product management, scientists, KOL surgeons and engineers.
• Create design documentation including part specifications, drawings, BOMs, test protocols and reports.
• Interface with supplier, manufacturing and quality engineering to prepare for scalable production of the models, definition of new processes, and comply with quality systems.
• Perform root cause investigations for design related issues and design failure mode analyses.
• Document and provide manufacturing process instructions to manufacturing trainer for new and revised models.
• Support successful introductions of new and revised models to the manufacturing line.
• Develop products that meet quality control standards and influence quality control procedures and practices.
• Sustain existing designs to achieve cost targets and maintain component supply continuity.
• Select and test product packaging and work with vendors to convey requirements and select most appropriate design.

Requirements

• Minimum 3 years experience in design and product development.
• Knowledge and execution of ISO 9001 quality systems.
• Comfortable working with animal tissue and knowledge of basic anatomy.
• Strong knowledge of surgical/laboratory terminology, equipment, materials, and procedures.
• Demonstrated hands-on problem solving of mechanical engineering challenges.
• Experience with component design and fabrication methods including machining, 3d printing, laser/die cutting and thermoforming.
• Proficient with CAD models (eg Solidworks) and creating engineering drawings.
• Familiar with all phases of the product development lifecycle, change and design control systems and processes (eg Agile).
• Able to work with standard computer applications: SmartSheet, Microsoft Office, Excel, Outlook, Powerpoint, and Visio.
• Excellent documentation and communication skills.
• Strong organizational skills and ability to support multiple fast-paced projects simultaneously.

Qualifications

• Minimum Bachelors Degree in Mechanical or Biomedical Engineering or equivalent.
• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
• Experience with SolidWorks and Fusion.
• Prior experience working in an FDA/ISO regulated environment, preferably medical device.
• Experience with fabrication methods including injection molding, hydrogel molding and silicone molding/casting.
• Experience resolving quality issues from production or assembly.
• Familiarity with Good Documentation Practices.
• Familiarity with Good Manufacturing Practices.
• Experience with design of experiments and statistical testing.
• Experience in lean manufacturing, six sigma and standardization techniques.
• Experience with packaging design, selection and vendor management.

Preferred Skills And Experience

• Experience with SolidWorks and Fusion.
• Prior experience working in an FDA/ISO regulated environment, preferably medical device.
• Experience with fabrication methods including injection molding, hydrogel molding and silicone molding/casting.
• Experience resolving quality issues from production or assembly.
• Familiarity with Good Manufacturing Practices.
• Experience with design of experiments and statistical testing.
• Experience in lean manufacturing, six sigma and standardization techniques.
• Experience with packaging design, selection and vendor management.