Sustaining Systems Design QE

Job#: 2089495

Job Description:
Sustaining Systems Design Quality Engineer II

? Maple Grove, MN

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 youre 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. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.