Design Assurance Engineer 2 (Medical Devices)

Location: Marlborough, MA, United States

Salary: $78,000–$122,100 annual base salary, bonus eligible

Company

hirify.global develops and supports medical device products and provides training and continued professional development for employees.

What you will do

• Support design assurance for new product development and on-market medical devices.
• Facilitate design controls across product development and sustaining activities.
• Support design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Coordinate design verification, validation, test method validation, and requirements analysis.
• Collaborate with R&D on risk management files and coordinate health risk assessments.
• Analyze product issues and assess the design impact and documentation requirements of product changes.

Requirements

• Technical bachelor's degree.
• Preferred: 2+ years of experience, ideally in the medical device industry.
• Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.
• Knowledge of FDA Quality System Regulations and design control requirements.
• Knowledge of ISO 13485, Medical Device Directive, and ISO 14971 risk management requirements.
• Ability to evaluate compliance, product risks, design changes, and verification and validation requirements.

Nice to have

• Experience with test method validation, root cause failure analysis, statistical methods, and design of experiments.
• Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards.

Culture & Benefits

• Comprehensive onboarding training and continued career development training.
• Collaborative work with R&D and cross-functional project teams.
• Bonus eligibility in addition to the annual base salary.