Product Development Quality Engineer

Position : Product Development Quality 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.