Principal Project Engineer Neurovascular
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Preferred Qualifications:
• 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%)
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
Must Have: Minimum Requirements (Must be evident on the resume)
• Bachelor’s degree
• 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
• 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:
• Degree in science, engineering, or healthcare related field.
• 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.
• 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.
Physical Requirements:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Position 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. 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). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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%)
RTG (Restorative Therapies Group) Overview
Do meaningful work, make a difference, and improve lives — starting with your own.
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment.
Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in.
The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome
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.
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.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $30.5b company with 90,000+ employees in more than 160 countries.
Medtronic is a $30.5b company with 90,000+ employees in more than 160 countries.
ABOUT MEDTRONIC:
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.
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Come for a job. Stay for a career.
