Design Assurance Engineer 3 (Medical Devices)

Location: Alajuela, Costa Rica or Newark, Delaware, United States

Annual base salary: $97,600–$152,700, plus bonus eligibility.

Company

hirify.global develops medical technologies and products, with this role focused on quality, compliance, and safety across the medical device lifecycle.

What you will do

• Support medical device quality, compliance, and safety from product development through market and post-market follow-up.
• Apply design controls and risk management to new products, manufacturing changes, and design changes.
• Develop and assess testable, measurable product and design requirements.
• Participate in verification, validation, test method development, and test method validation.
• Conduct health risk assessments for on-market products and risk assessments for new product development programs.
• Collaborate with multifunctional teams, lead critical tasks, and create objective evidence for quality and safety compliance.

Requirements

• Bachelor’s degree, preferably in Engineering, Biomedical Engineering, or a related field.
• Prior experience in medical devices or another highly regulated industry.
• Experience with FDA Medical Devices 820 Quality System Regulation, especially design controls; ISO 13485; ISO 14971:2019; EU MDD 93/42/EEC; and EU MDR 2017/745.
• Experience with risk management, quality systems, design and product requirements, verification and validation, and regulatory compliance.
• Experience with Good Laboratory Practices, usability, reliability, electrical safety, and software standards and regulations.
• Experience with requirements analysis, test method validation, root cause failure analysis, statistical methods, and design of experiments.
• Fluent written and verbal English, with strong technical writing and presentation skills.
• Ability to work effectively on project teams, lead critical tasks, assess product and project documentation, and communicate compliance assessments.
• Ability to apply Deming Cycle / PDCA principles and demonstrate analytical, critical-thinking, organizational, problem-solving, and collaboration skills.

Nice to have

• Master’s degree or PhD.

Culture & Benefits

• Comprehensive training when joining and continued development and training throughout the career.
• Bonus-eligible compensation.
• Equal opportunity employment inclusive of disability and veterans.