Integrated Resources, Inc ( IRI )
Design Quality Engineer
Integrated Resources, Inc ( IRI ), Osseo, Minnesota, United States, 55311
Get AI-powered advice on this job and more exclusive features.
Overview
Client is seeking a Sustaining Systems Design Quality Engineer II to join our Interventional Cardiology (IC) division in Maple Grove, MN. This hybrid role supports design quality assurance for medical electrical equipment/systems (MEE). You will contribute to sustaining engineering initiatives by ensuring product safety, compliance, and continuous improvement in collaboration with cross-functional teams. Responsibilities
Lead and manage design change projects including scoping, assessment, and implementation. Create and maintain Design History Files, and Design Input/Output documentation. Develop and update Risk Management Files, including Hazard Analysis, Task Analysis, and Design FMEA. Author and execute Design Verification, Validation, and Usability testing protocols and reports. Support complaint investigations, NCEPs, CAPAs, and PIRs with design quality expertise. Apply structured problem-solving methodologies to resolve product and process issues. Ensure compliance with internal quality procedures, regulatory standards, and design control requirements. Required Qualifications
Bachelor’s degree in mechanical, Electrical, or Biomedical Engineering (must be listed on resume). 3–5 years of experience in a design quality engineering role (not manufacturing-focused). Proven experience with Hazard Analysis and Risk Controls. Design Failure Mode and Effects Analysis (DFMEA). Complaint Analysis, NCEP, and CAPA management. Design control within the medical device industry. Strong collaboration and communication skills (verbal and written). Demonstrated ability to work independently and in cross-functional team settings. Preferred Qualifications
Prior experience working with medical electrical systems or cardiology-related devices. Familiarity with FDA regulations, ISO 13485, and IEC 60601 standards. Details
Location: Hybrid – Maple Grove, MN Work Schedule: 3 Days Onsite / 2 Days Remote Duration: 12-Month W2 Contract (High Possibility of Full-Time Conversion) Seniority level: Mid-Senior level Employment type: Contract Job function: Science, Research, and Engineering Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Integrated Resources, Inc ( IRI ) by 2x
#J-18808-Ljbffr
Client is seeking a Sustaining Systems Design Quality Engineer II to join our Interventional Cardiology (IC) division in Maple Grove, MN. This hybrid role supports design quality assurance for medical electrical equipment/systems (MEE). You will contribute to sustaining engineering initiatives by ensuring product safety, compliance, and continuous improvement in collaboration with cross-functional teams. Responsibilities
Lead and manage design change projects including scoping, assessment, and implementation. Create and maintain Design History Files, and Design Input/Output documentation. Develop and update Risk Management Files, including Hazard Analysis, Task Analysis, and Design FMEA. Author and execute Design Verification, Validation, and Usability testing protocols and reports. Support complaint investigations, NCEPs, CAPAs, and PIRs with design quality expertise. Apply structured problem-solving methodologies to resolve product and process issues. Ensure compliance with internal quality procedures, regulatory standards, and design control requirements. Required Qualifications
Bachelor’s degree in mechanical, Electrical, or Biomedical Engineering (must be listed on resume). 3–5 years of experience in a design quality engineering role (not manufacturing-focused). Proven experience with Hazard Analysis and Risk Controls. Design Failure Mode and Effects Analysis (DFMEA). Complaint Analysis, NCEP, and CAPA management. Design control within the medical device industry. Strong collaboration and communication skills (verbal and written). Demonstrated ability to work independently and in cross-functional team settings. Preferred Qualifications
Prior experience working with medical electrical systems or cardiology-related devices. Familiarity with FDA regulations, ISO 13485, and IEC 60601 standards. Details
Location: Hybrid – Maple Grove, MN Work Schedule: 3 Days Onsite / 2 Days Remote Duration: 12-Month W2 Contract (High Possibility of Full-Time Conversion) Seniority level: Mid-Senior level Employment type: Contract Job function: Science, Research, and Engineering Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Integrated Resources, Inc ( IRI ) by 2x
#J-18808-Ljbffr