Sustaining Systems Design QE

Sustaining Systems Design Quality Engineer II

Partnering with a leading Medical Device company | Apex Systems

Are you ready to make a meaningful impact in the medical device industry? Apex Systems is partnering with one of our top clients in Interventional Cardiology (IC) to find a Sustaining Systems Design Quality Engineer II to join their growing team in Maple Grove, MN.

This is a fantastic opportunity to contribute to the quality assurance of cutting-edge medical electrical equipment/systems (MEE) while advancing your career in a collaborative and innovative environment.

Key Responsibilities:

• Lead design change projects from scoping through implementation.
• Maintain and update Design History Files and Design Input/Output documentation.
• Manage risk documentation including Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Validation, and Usability protocols and reports.
• Support resolution of PIRs, CAPAs, and NCEPs with design quality expertise.
• Apply systematic problem-solving methodologies to address quality issues.
• Ensure compliance with internal quality policies and external regulatory standards.

Quality Systems Responsibilities:

• Embed quality into every aspect of work by adhering to all documented quality processes and procedures.

Qualifications:

• Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering (must be clearly stated on resume).
• 3–5 years of relevant experience in design quality engineering.
• Strong background in design controls, risk management, and medical device standards.
• Experience with corrective and preventive actions (CAPA).
• Excellent collaboration and communication skills in both team and independent settings.

Why This Role?

• Work with a respected and innovative medical device company.
• Be part of a high-performance cross-functional team.
• Make a direct impact on patient safety and product quality.
• Grow your skills in a rapidly expanding division.

If you're passionate about quality engineering and ready to take the next step in your career, we'd love to hear from you!

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.