Sr. Engineer, Quality Product Design (Medical Devices)

TL;DR

Sr. Engineer, Quality Product Design (MedTech): Ensuring product quality and regulatory compliance for electromechanical software products throughout the development lifecycle with an accent on risk mitigation and design controls. Focus on managing risk management files, performing audits, and ensuring compliance with ISO 13485 and FDA regulations.

Location: Must be based in Wayne, NJ (Hybrid: 4 days onsite, 1-2 days remote)

Salary: $115,000 – $130,000 plus annual bonus of 10%

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 procedures, and operating rooms.

What you will do

• Ensure product development and design changes comply with Design Controls, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Manage the product development life cycle for electromechanical software products to ensure safety and quality.
• Lead risk analysis and management, implementing mitigation strategies and maintaining risk management files.
• Develop and implement quality assurance plans, protocols, and standards.
• Support design verification and validation, including protocol development and report generation.
• Perform periodic audits and ensure readiness for internal and external inspections.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• Minimum of 5 years of experience in New Product Development or Sustaining Engineering.
• Experience in the medical device industry or other highly regulated fields (biotech, pharma, aerospace).
• Proficiency in quality tools and methodologies such as Six Sigma and FMEA.
• Knowledge and demonstrated application of ISO 14971 and ISO 13485 standards.

Nice to have

• ASQ Certified Quality Engineer or ASQ Certified Reliability Engineer.
• Six Sigma Green Belt certification.
• Project management and leadership experience.

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Wellness initiatives and Health Assistance Resources.
• Tuition reimbursement and commuter benefits.