Principal Equipment Design Engineer (Medical Devices)

Location: Lafayette, Colorado, United States; onsite four days per week

Salary: $124,000–$186,000 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Lead the mechanical design and development of custom machines, automation systems, tooling, fixtures, and manufacturing equipment for medical device development and production.
• Create and maintain 3D CAD models, complex assemblies, detailed drawings, bills of materials, and controlled engineering documentation in SolidWorks.
• Support equipment qualification, validation, FAT, SAT, commissioning, troubleshooting, and post-installation performance investigations.
• Develop requirements, functional and design specifications, risk assessments, test plans, and design review materials.
• Perform tolerance stack-ups, failure analysis, root cause investigations, and design-for-manufacturability and assembly assessments.
• Manage project scope, schedules, risks, technical deliverables, and stakeholder communication while mentoring engineers and leading cross-functional execution.

Requirements

• Baccalaureate degree with at least 7 years of relevant experience, or a master’s degree with 5 years, or a PhD with 3 years.
• Significant experience in machine design, automation, manufacturing equipment, or capital equipment development.
• Advanced SolidWorks proficiency, including complex assemblies, detailed mechanical drawings, and formal design documentation.
• Experience producing accurate, detailed, and controlled engineering documentation in regulated or highly quality-focused environments.
• Ability to work onsite in Lafayette, Colorado, four days per week.
• U.S. work authorization sponsorship is offered for Principal-level roles and above; sponsorship eligibility is subject to company requirements.

Nice to have

• Mechanical Engineering degree and knowledge of mechanical design principles, GD&T, tolerance analysis, material selection, and manufacturing processes.
• Experience with automation, robotics, motion control, pneumatics, vision systems, or mechatronics.
• Working knowledge of PDM/PLM systems, FEA, structured engineering change processes, and medical device equipment validation.
• Experience with IQ/OQ/PQ protocols, test methods, validation summaries, and regulated document and change control.
• Experience leading technical projects and collaborating with Quality, Validation, Manufacturing, Controls, and Operations.

Culture & Benefits

• Onsite collaboration supports professional growth and cross-functional engineering work.
• Health, dental, vision, life, disability, and flexible spending benefits are available to eligible regular employees.
• Benefits include 401(k) contributions and match, paid time off, paid holidays, incentive plans, and an employee stock purchase plan.
• Tuition assistance, employee assistance, and global well-being resources are available.