Sr. Engineer, Design Quality (MedTech)

TL;DR

Sr. Engineer, Design Quality (MedTech): Ensuring product design and lifecycle changes meet all applicable quality and regulatory requirements for infection control consumables with an accent on design assurance and compliance. Focus on owning design control execution, risk management activities, and change governance within PLM systems.

Location: Remote (US), 25% travel as needed

Salary: $96,000–$120,000 + 4% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care, cardiovascular, and sterile reprocessing.

What you will do

• Serve as the Quality lead on design and development programs, ensuring robust implementation of design controls.
• Own risk management activities per ISO 14971, including hazard analyses and FMEAs.
• Govern change management within the Arena PLM system, including the review and approval of Engineering Change Orders (ECOs).
• Define and drive critical-to-quality (CTQ) requirements to align design intent with product performance.
• Lead audit readiness efforts and support internal and external audits for FDA and EU MDR compliance.
• Mentor junior engineers in design quality best practices and regulatory compliance.

Requirements

• Bachelor’s degree in science, engineering, or a related technical field.
• 5+ years of relevant experience in the medical device industry, with several years specifically in Design Quality or Quality Engineering.
• Deep knowledge of FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, and EU MDR 2017/745.
• Hands-on experience with PLM systems (Arena preferred) and familiarity with GD&T standards.
• Must have the education and experience to comply with U.S. and Worldwide medical device regulations.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Wellness initiatives, Health Assistance Resources, and Tuition Reimbursement.
• Health and Dependent Care Flexible Spending Accounts.