Senior Design Quality Engineer (Medical Devices)

TL;DR

Senior Design Quality Engineer (Medical Devices): Integrating quality requirements throughout the product development lifecycle for cranial and spinal technologies with an accent on risk management, design verification, and validation. Focus on ensuring regulatory compliance, maintaining Design History Files, and facilitating seamless design transfers to manufacturing.

Location: Onsite in Fort Worth, TX (4 days a week). Must be authorized to work in the US without sponsorship.

Salary: $98,400 - $147,600

Company

Global leader in healthcare technology focused on alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Integrate Design Quality requirements from concept through commercialization and sustaining engineering.
• Lead risk management activities, including identification, assessment, mitigation, and traceability.
• Execute design verification and validation to ensure products meet safety and regulatory standards.
• Develop and maintain Design History File (DHF) records and objective evidence for compliance.
• Collaborate with Operations and Manufacturing to ensure successful design transfer and process compliance.
• Perform statistical analysis, inspection planning, and support corrective and preventive actions.

Requirements

• Bachelor’s in Engineering or Technical field (4+ years exp), Master’s (2+ years exp), or PhD.
• Must possess unrestricted U.S. work authorization (no sponsorship provided).
• Knowledge of Design Controls and Risk Management (ISO 14971).
• Familiarity with FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.
• Ability to work onsite in Fort Worth, TX 4 days per week.

Nice to have

• Experience in medical device or other highly regulated industries.
• Experience supporting combination products (drug delivery systems, biologics).
• Proficiency in root cause investigations and quality improvement methodologies.
• Strong cross-functional collaboration skills with R&D, Regulatory, and Clinical teams.

Culture & Benefits

• Competitive base salary and the hirify.global Incentive Plan (MIP).
• Comprehensive Health, Dental, and Vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and a global well-being program (Simple Steps).