Description

Job description:

Essential Job Duties:

• (Specific responsibilities and tasks an individual would be expected to perform in the role.
• Functional people manager may determine additional 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 suppliers, manufacturing, and quality engineering to prepare for scalable production of the models, define 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 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:

• Minimum 2 years’ experience in design and product development.
• Knowledge and execution of ISO 9001 quality systems.
• Ability to work safely with animal tissue and apply knowledge of basic anatomy as required by the position.
• Working knowledge of surgical and laboratory terminology, equipment, materials, and procedures relevant to product development.
• 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.
• Familiarity with Good Documentation Practices.
• Strong organizational skills and ability to support multiple fast-paced projects simultaneously.
• Required Education and Training (As applicable - Specific education and training that an individual must possess to successfully perform in the job)
• Minimum bachelor’s degree in mechanical or biomedical engineering or equivalent.

Preferred Skills:

• . 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

Key Skills

Education

Any Graduate