Development Engineer 2

Responsibilities: 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.

Our client, a Medical Technology company, is looking for a Development Engineer 2 for their Durham, NC location.
 
Responsibilities:

• 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.
• The Product Development Engineer will lead design and development projects for client training models.

 
Requirements:

• 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 client means joining a team dedicated to providing the highest quality and realistic training experience for our customers.
• 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.
• Minimum Bachelors Degree in Mechanical or Biomedical Engineering or equivalent.
• 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.

 
Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities