Summary:
A leading Surgical Medical Device company based in Minneapolis, MN is looking for its next Principal Quality Engineer. Joining a team of 30+ Quality Engineers, the ideal candidate will have extensive Quality Engineering knowledge and experience in the Medical Device Industry. They are a self-starter able offer guidance to Quality Engineers at all levels.
Qualifications:
* Bachelor's Degree in Engineering, Science, or a related Technical Field with a minimum of 7 years of experience in Engineering and/or Quality roles
* Experience in conducting risk assessments in manufacturing, operations, and/or software development environments
* Familiarity with medical device compliance standards, including IEC 14971, ISO 13485, IEC 62304, HIPAA, FDA regulations, Security Standards, and Data Privacy laws
* Proficiency in preparing technical reports, business correspondence, and standard operating procedures
* Excellent communication skills
* Exposure to data-driven insight solutions such as Minitab
* Working knowledge of integrated digital health systems, including consumer products such as those offered by Apple Inc. and Android platforms
Responsibilities:
* Implement best practices in risk management throughout the product lifecycle and facilitate post-production issue triage
* Serve as a subject matter expert for assessing post-market risk and providing recommendations for potential field actions
* Collaborate with cross-functional teams, including members from Medical Safety, Regulatory, and R&D, on complex projects
* Utilize product functional knowledge, human physiology, clinical therapy performance knowledge, and risk management principles to estimate risks
* Lead and conduct post-market risk management activities, including authoring Health Hazard Evaluations (HHE) and Issue Impact Assessments (IIA)
* Provide field action recommendations for complex field issues using critical thinking skills
* Author CFR 806 Corrections and Removals assessments for FDA reportability
* Participate in cybersecurity risk assessments as required
* Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discussing harm severity sources and estimating the probability of harm occurrence
* Lead CAPA (Corrective and Preventative Action) projects and participate in regulatory audits and inspections as a Subject Matter Expert (SME)
* Lead quality improvement projects for risk management procedures and mentor new hires and peers
* Perform any additional tasks assigned by management
Benefits:
* Medical, Prescription, Dental, Vision Coverage
* Employee Assistance Program
* Mental Health Resources
* Disability Coverage
* Life insurance
* Critical Illness and Accident Insurance
* Legal and Identity Theft Protection
* 401(k) with company match
* Flexible Time Off (FTO) and 11 paid holidays
