Medical Training Model Product Development Engineer

Pay Range: $43.33hr - $48.33hr Job Overview:
The Product Development Engineer will lead design and development projects for client training models. This position requires a self-driven candidate 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 the organization means joining a team dedicated to providing high quality and realistic training experiences. 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, key opinion leader surgeons, and engineers. Create design documentation including part specifications, drawings, bill of materials (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 compliance with quality systems. Perform root cause investigations for design-related issues and 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 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 the most appropriate design. Required

Skills and Experience:

Minimum 2+ years of experience in design and product development. Knowledge and execution of ISO 9001 quality systems. Comfortable working with animal tissue and possesses 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 (e.g., Solid Works) and creating engineering drawings. Familiar with all phases of the product development lifecycle, change control, and design control systems and processes (e.g., Agile). Ability to work with standard computer applications including Smartsheet, Microsoft Office, Excel, Outlook, PowerPoint, and Visio.

Excellent documentation and communication skills, with familiarity in Good Documentation Practices. Strong organizational skills and the ability to support multiple fast-paced projects simultaneously. Required Education and Training:
Minimum Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or equivalent. Preferred

Skills and Experience:

Master's 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 devices.

Experience with fabrication methods including injection molding, hydrogel molding, and silicone molding/casting. Experience resolving quality issues from production or assembly, with familiarity in 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. Benefits:
Our Benefits Include:
Medical, Dental, and Vision Insurance 401(k) Retirement Plan Health Savings Account (HSA) Disability Insurance (Short-Term and Long-Term) Life and AD&D Insurance Paid Sick Leave (where required by applicable state or local law) Supplemental Insurance Plans Identity Theft Protection Pet Insurance Employee Wellness Programs Employee Assistance Program (EAP) Career Growth and Professional Development Opportunities

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates.…