Principal Sustaining Engineer - Medical Device

Principal Sustaining Engineer (Structural Heart / Catheter Systems)Location: Minneapolis, MNWe are a growing medical device company focused on advancing next generation structural heart technologies designed to improve patient outcomes and restore healthy cardiac function. Our team is dedicated to developing innovative transcatheter heart valve solutions that combine cutting edge engineering, clinical insight, and advanced biomaterial technologies.The Principal Sustaining Engineer is a highly skilled and experienced technical leader responsible for supporting and improving existing products throughout their lifecycle. This contract role is critical in ensuring continued product performance, safety, reliability, and regulatory compliance within a highly regulated medical device environment.Key Responsibilities• Lead sustaining engineering activities including design modifications, process improvements, and component or material changes to ensure product quality and reliability• Provide technical expertise to investigate and resolve product performance issues, field complaints, and non conformances• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for product related issues• Support internal and contract manufacturing teams with troubleshooting production issues and optimizing manufacturing processes• Evaluate and qualify alternate materials, suppliers, and manufacturing processes to support continuity of supply and cost reduction initiatives• Prepare and review technical documentation including engineering change orders (ECOs), risk assessments, validation protocols, test reports, and verification activities• Ensure compliance with FDA, ISO 13485, MDR, and other applicable medical device regulations and standards• Support audits, regulatory submissions, and quality system activities as requiredQualifications• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline. Master's degree preferred• Minimum of 10 years of experience in sustaining engineering, product development, or R&D within the medical device industry• Strong understanding of FDA 21 CFR Part 820, ISO 13485, EU MDR, and medical device quality systems• Experience with risk management, design controls, verification and validation activities, and product lifecycle management• Proficiency with engineering tools such as CAD, FMEA, and statistical analysis methodologies• Experience supporting complex electromechanical or implantable medical device products preferred• Strong analytical, troubleshooting, and problem solving skills with a hands on engineering approach• Ability to lead cross functional initiatives in a fast paced, regulated environment• Excellent communication, organizational, and project management skillsWhat We Offer• Opportunity to contribute to innovative medical device technologies that improve patient lives• Collaborative, fast paced, and mission driven engineering environment• High visibility role with meaningful impact across product development and sustaining engineering initiatives• Opportunity to work alongside experienced leaders within the structural heart and medical device industryEqual Opportunity StatementWe are an equal opportunity employer committed to creating an inclusive environment for all employees. Employment decisions are made without regard to race, religion, color, national origin, sex, age, disability, veteran status, or any other protected characteristic in accordance with applicable laws.