Design Quality Engineer II (Medtech)

TL;DR

Design Quality Engineer II (Medtech): Ensuring product quality, reliability, and regulatory compliance for sustaining engineering and product change activities within the Acute Care & Monitoring unit with an accent on design controls, risk management, and regulatory standards. Focus on executing compliant design changes, managing risk documentation (DFMEAs), and supporting V&V strategies for medical devices.

Location: Lafayette, Colorado, USA. Must possess unrestricted U.S. work authorization.

Salary: $79,200 - $118,800 USD

Company

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

What you will do

• Review product designs to assess impacts on patient safety, reliability, and regulatory compliance.
• Manage design change activities in accordance with QMS, ISO 13485, EU MDR, and FDA QMSR expectations.
• Develop and maintain risk management documentation, including Risk Management Plans, hazard analyses, and DFMEAs per ISO 14971.
• Review and provide input for verification and validation (V&V) strategies, test plans, and reports.
• Provide quality engineering support for sustaining initiatives across electrical, software, mechanical, and optical disciplines.
• Support investigations, CAPA activities, root cause analysis, and failure analysis for released product quality concerns.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of relevant Engineering or Quality experience in the medical device or another regulated industry.
• Working knowledge of Quality Management Systems (QMS) and regulated product development processes.
• Familiarity with ISO 13485, FDA QMSR, and EU MDR regulatory frameworks.
• Experience with risk management principles (ISO 14971) and design controls.
• Must have unrestricted U.S. work authorization at the time of hire.

Nice to have

• Experience with electronic hardware systems, PCB assemblies, and IEC 60601 standards.
• Proficiency in statistical methods (ANOVA, GR&R) and software such as Minitab.
• Familiarity with reliability testing (HALT/HASS) or biocompatibility testing.
• Lean Six Sigma Green/Black Belt or ASQ certifications (CQE, CRE, CQA).

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and Life insurance.