JOB DESCRIPTION:

Currently recruiting for a Sustaining Systems Design Quality Engineer II in our Maple Grove, MN location. This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of the client. The Design Quality Engineer II will support the application of design controls to projects, focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products.

Responsibilities:

• Ownership of design change projects, including scoping, assessment, and implementation.
• Develop, update, and maintain the Design History File and Design Input / Output documentation.
• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Requirements:

• 3-5 Years with BS. Degree must be clearly stated on resume.
• Bachelor’s degree in mechanical, electrical, or biomedical engineering, highly preferred.
• Experience with design control, risk management, and medical device standards compliance.
• Experience with corrective and preventive action.
• Adaptable and effective collaborator in a team environment and in self-directed work.
• Strong communication skills (verbal & written).

• Ownership of design change projects, including scoping, assessment, and implementation.
• Develop, update, and maintain the Design History File and Design Input / Output documentation.
• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements