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Design Quality Engineer II (Maple Grove)

Design Quality Engineer II (Maple Grove)

JCW GroupMaple Grove, MN, US
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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

  • Bachelors degree in mechanical, electrical, or biomedical engineering (preferred).
  • 35 years of experience in design quality or engineering roles.
  • Hands-on experience with design controls, risk management, and medical device standards.

    • Required Skills

  • Strong problem-solving, documentation, and communication skills.

    • Preferred Skills

  • Experience in the cardiovascular field is a plus.
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