Product Development Engineer 2

Maxonic, Inc. is seeking a Product Development Engineer 2 on a contract basis for onsite work in Durham, NC. This role leads engineering design and development activities for client training models, from prototyping and testing through documentation and scalable manufacturing introduction.

Location and Employment Details

• Location: Durham, NC (onsite)
• Job type: Contract
• Compensation: USD 48 per hourly (up to)
• Pay: Up to $48.00 per hour
• Work arrangement: In person

Role Summary

The Product Development Engineer 2 supports product development efforts for new models and design changes. The position focuses on improved user experience, training effectiveness and realism, manufacturability, reliability, and cost. Responsibilities include rapid prototyping, engineering documentation, root cause investigations, and coordination with supplier, manufacturing, and quality engineering teams to introduce revised models to production.

Responsibilities

• Support product development projects for new models and design changes aimed at improving user experience, training effectiveness and realism, manufacturability, reliability, and cost.
• Address 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.
• Coordinate with suppliers, manufacturing, and quality engineering to prepare for scalable production, define new processes, and comply with quality systems.
• Conduct root cause investigations for design-related issues and perform design failure mode analyses.
• Document and provide manufacturing process instructions to the 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 support 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 communicate requirements and select appropriate design.

Requirements

• Minimum 2 years of 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 and 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 or die cutting, and thermoforming.
• Proficient with CAD models (e.g., SolidWorks) and creating engineering drawings.
• Familiar with phases of the product development lifecycle, including change and design control systems and processes (e.g., Agile).
• Ability to work with standard computer applications: SmartSheet, Microsoft Office, Excel, Outlook, PowerPoint, Vision.
• Excellent documentation and communication skills; familiarity with Good Documentation Practices.
• Strong organizational skills and ability to support multiple fast-paced projects at the same time.
• Minimum Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent).

Technologies

• ISO 9001
• SolidWorks
• SmartSheet
• Microsoft Office (Excel, Outlook, PowerPoint)
• Vision

Preferred Skills and Experience

• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
• Experience with SolidWorks.
• Prior experience working in an FDA or ISO regulated environment, preferably medical device.
• Experience with fabrication methods including injection molding, hydrogel molding, and silicone molding or casting.
• Experience resolving quality issues from production or assembly, with 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.

How to Apply

• Apply with your most current resume.
• For details, contact Vishal Pal at [email protected] or (408) 400-2309.