What are the responsibilities and job description for the Post-Market Surveillance Engineering Manager - Neurovascular - Irvine, CA (Onsite) position at Medtronic?
Careers That Change Lives
In this exciting role as Post-Market Surveillance Engineering Manager, you will be responsible for leading and managing the Post-Market Surveillance engineering team to ensure product safety by timely resolution of post-market quality and patient safety issues. In this role, you will be responsible for ensuring adequate engineering evaluation of field reported complaints including trends in patient impact, device failures, root cause investigation, and on-going risk assessment using data analytics and signal detection for the Neurovascular product portfolio. In addition, you will provide leadership, oversight, coaching, and training to the Post-Market Surveillance engineering team on a broad range of topics including risk management, post-market surveillance, statistical methods, and data analytics to positively influence post-market products and ensure conformance to all applicable regulatory requirements.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
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Neurovascular Operating Unit: The Neurovascular Operating Unit provides a comprehensive portfolio of proven neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Strike Care.
Location: Irvine, CA (Onsite)
Ability to travel up to: Less than 25%
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Oversee and manage a team of Post-Market Surveillance engineers who lead the investigation of issues impacting fielded product in collaboration with Operations, Supplier Quality, Design Quality, R&D, and Medical Safety to assess risk and drive appropriate action on fielded product.
- Lead or support the Field Issue Risk Evaluation process, Product Evaluation Board activities for complaint trending and signal analysis.
- Adept at using large data sets using a variety of mining/data analysis methods and understanding of fundamental Risk Management application.
- Lead complex issue investigations and support product holds, field corrective actions, and regulatory requests for additional information.
- Comprehensive understanding of all Neurovascular products and clinical uses.
- Lead or participate in CAPAs related to post-market activities.
- Represent Medtronic Neurovascular as appropriate in FDA, Notified Body and internal/external audits.
- Manage resource allocation across post-market surveillance engineering team.
- Drive change, demonstrate effective decision making, and provide direction for post-market surveillance.
- Provide guidance and development opportunities for the Post-Market Surveillance engineering team.
- All other duties as assigned or required.
Must Have (Minimum Requirements)
- Bachelor’s degree in engineering, Science or Technical Discipline is required with a minimum of 5 years of post-market surveillance or risk management experience.
- OR advance degree with a minimum of 3 years of post-market surveillance or risk management experience.
Nice to Have (Preferred Qualifications)
- Experience with standards and regulations including ISO 13485, Medical Device Directives, European Union Medical Device Directives, Medical Device Reporting, Quality System Regulation, and FDA requirements.
- 5 years in post-market surveillance or risk management with at least 3 years in the medical device industry
- Quality Certifications: i.e. Certified Quality Engineering/Manager, Certified Quality Auditor
- Previous supervisory or managerial experience
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
