Design Quality Engineer II (Maple Grove)JCW Group • Maple Grove, MN, United States
Design Quality Engineer II (Maple Grove)
JCW Group • Maple Grove, MN, United States
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job_description.job_card.job_descriptionBachelors 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. Strong problem-solving, documentation, and communication skills. Experience in the cardiovascular field is a plus.
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
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Quality Engineer Ii • Maple Grove, MN, United States