Principal Project Engineer Neurovascular
• 7+ years of relevant experience with Bachelor’s degree/ 5+ years of relevant experience with a Master’s degree
• 4+ years of experience in project or program management
• Direct experience in regulated environments, preferably in medical device
• Working knowledge of project management techniques and DMAIC problem solving methodologies
Preferred Qualifications:
• 10+ years of experience with relative ISO and FDA regulations and Good Manufacturing Practices (GMP)
• 8+ years of experience with medical device product development, design verification/validation, risk management, reliability engineering, statistics, process validation and Quality systems
• 7+ years of project management and critical path analysis
• Demonstrated engineering and problem solving skills. Able to solve complex problems that require creativity.
• Demonstrated ability to coach technical professionals to achieve maximum performance
• Effective at influencing and building strong working relationships across all levels and diverse cultures
• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
• Master’s degree in science or engineering is preferred.
• Experience with improvement tools preferred: six sigma, lean manufacturing, and theory of constraints.
• Demonstrated knowledge of clinical/technical applications of medical devices and human anatomy
• Experience negotiating directly with FDA and other agencies in inspections and regulatory submissions.
• PMP Certification
• ASQ Certified Quality Manager, Engineer or Six Sigma Black Belt a plus
• Experience with advanced statistical methods: SPC, DOE, ANOVA and others
• Experience with Medical Device regulations 21 CFR Part 820 is preferred.
• The employee is required to be independently mobile
• The employee must be able to travel independently to various Medtronic buildings/sites.
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to travel by car and by airplane (<10%)
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
Medtronic is a $30.5b company with 90,000+ employees in more than 160 countries.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
EEO STATEMENT:
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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