Design Assurance Engineer

Position: Design Assurance Engineer

Location: Pennsylvania

Experience: 5 8 years

Duration: 12 months contract

Job Overview

The role focuses on supporting design controls, verification and validation activities, and maintaining documentation throughout the product lifecycle for medical device products. You'll work with cross-functional teams to review design updates, manage risks, and ensure that design requirements are well-defined, compliant, and consistently met. This job suits someone who enjoys digging into technical details, understands mechanical drawings, and is comfortable working within regulated environments.

Key Responsibilities

• Review, update, and maintain design requirements and design change documentation.
• Support V&V activities by drafting, reviewing, and executing test protocols and related documentation.
• Maintain and update risk management files, ensuring changes are accurately documented.
• Participate in internal training and follow established procedures, standards, and quality system requirements.
• Collaborate closely with engineering, R&D, quality, and supply chain teams to support ongoing product improvements.
• Review mechanical drawings and provide technical input to ensure alignment with design intent.
• Maintain documentation within DHF and ensure all activities meet regulatory and internal compliance expectations.
  
  

Must-Have Skills

• Strong engineering background with hands-on experience in design controls, V&V, DHF documentation, and risk management.
• Ability to read and interpret mechanical drawings.
• Solid understanding of documentation practices within regulated industries, ideally medical devices.
  
  

Nice-to-Have Skills

• Experience supporting both new product development and lifecycle management.
• Background in orthopedic or trauma device development.
  
  

Education

• Bachelor's degree in Engineering or a related technical field.