Design Quality Engineer II

About the Company

A leading global medical device company is seeking a Design Quality Engineer II to support sustaining systems engineering within a fast-growing cardiovascular division. This role will focus on ensuring design control, compliance, and product safety across medical electrical equipment and systems.

About the Role

This role will focus on ensuring design control, compliance, and product safety across medical electrical equipment and systems.

Responsibilities

• Lead and support design change projects, including scope, assessment, and implementation.
• Develop and maintain documentation such as Design History Files, risk management files, and design input / output records.
• Create and execute verification, validation, and usability protocols to meet regulatory requirements.
• Support investigations and resolutions for quality issues (CAPAs, PIRs, NCEPs).

Qualifications

Required Skills

Preferred Skills