Education Requirement: BS in Engineering (Mechanical or Biomedical preferred)

Training Skill Requirement: SolidWorks, Microsoft Office, MS Teams, some programming, design
control processes, standards and policies

Experience Requirement: experience with controlled documents, project management methods, design
and development practices

Reports to: Executive Vice President, Product Development and Engineering at Healthy Design

Responsibilities:
• Execute and maintain Healthy Design’s product development pipeline
• Execute product development projects in compliance with FDA 21 CFR 820.30 guidance for
design controls
• Execute detailed design of new products and associated drawing packages
• Own risk management practices as applied to product development and design
• Carry out continuous improvements, product lifecycle change management, and engineering
investigations and responses to complaints and CAPAs
• Execute R&D and rapid prototyping (3D printing, laser cutting, and fabrication), concept
development, and early phase project planning
• Collaborate with Manufacturing to develop manufacturing and assembly processes and work
instructions
• Collaborate with Clinical Development to define user needs and usability requirements
• Develop and execute verification, validation, and in-line testing plans and processes
• Oversee engineering interns and academic sponsorships (SEED, Capstone, etc.)

Authorities:
• Supervisor for engineering interns, contractors
• Owner (with EVP) of product development portfolio and priority setting
• Development (with EVP) of and execution against engineering budget
• Ownership of Design History File (DHF)