Senior Design Quality Engineer (Medtech)

TL;DR

Senior Design Quality Engineer (Medtech): Ensuring product quality, safety, and regulatory compliance for medical devices throughout the product lifecycle with an accent on design controls, risk management, and verification/validation strategies. Focus on partnering with cross-functional teams to drive quality standards, lead design quality activities, and ensure successful commercialization of complex cranial and spinal technologies.

Location: Must be based in Lafayette, CO (Onsite 4 days a week)

Salary: $98,400 – $147,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Serve as the Design Quality representative on new product development and sustaining engineering projects.
• Lead design quality activities including design controls, risk management (DFMEA), and verification/validation strategies.
• Review and approve design documentation, engineering changes, protocols, and technical reports.
• Partner with R&D, Manufacturing, and Regulatory Affairs to assess quality impact and ensure compliance.
• Support design transfer, supplier integration, and manufacturing readiness for commercialization.
• Collaborate on establishing inspection methods and quality standards to ensure product reliability.

Requirements

• Bachelor’s degree in Engineering or Technical discipline with 4+ years of relevant experience, or Master’s with 2+ years, or PhD with 0+ years.
• Must possess unrestricted U.S. work authorization (sponsorship is not provided for this level).
• Must be able to work onsite in Lafayette, CO 4 days per week.
• Experience with medical device design controls and quality system requirements.
• Ability to lead cross-functional teams and influence decision-making without direct authority.

Nice to have

• Experience with FDA Quality System Regulation (QSR), ISO 13485, and EU MDR.
• Experience with system-level medical devices, including capital equipment.
• Knowledge of design transfer, supplier quality, and labeling requirements.

Culture & Benefits

• Competitive salary and short-term incentive plans (MIP).
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.