Job Title - Product Development Engineer
Location - Durham NC 27703
Length - Contract (10 Months+)
Description -
Primary Function of Position
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. Joining Intuitive means joining a team dedicated to providing the highest quality and realistic training experience for our customers.
Essential Job Duties
• Support product development projects for new models and design changes for improved user experience, training effectiveness and realism, manufacturability, reliability, and cost.
• 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.
• Lead 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.
• Test product packaging and work with vendors to convey requirements and select most
appropriate design.
Required Skills and Experience (Specific skills, knowledge, and experience
that an individual must possess in order to successfully perform in job)
• Minimum 2 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).
• Ability to work with standard computer applications: SmartSheet, Microsoft office, excel,
outlook, powerpoint, visio.
• Excellent documentation and communication skills. Familiarity with Good Documentation Practices.
• Strong organizational skills and ability to support multiple fast-paced projects simultaneously.
Required Education and Training
• Minimum Bachelors Degree in Mechanical or Biomedical Engineering or equivalent.
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
• Experience with SolidWorks.
• 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.
