Product Development Engineer

Job Title: Product Development Engineer
Location: Chapel Hill, NC (Onsite)
Duration: 06+ Months (potential contract extension or conversion to full-time)

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

• 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.

• 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 Solid Works) 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:
  Smart Sheet, 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 bachelor's degree in mechanical or biomedical engineering or equivalent.

None

• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
• Experience with Solid Works.
• 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.