1+ months

Principal Project Engineer Neurovascular

Medtronic
Irvine, CA 92604
Principal Project Engineer Neurovascular

Location:

Irvine, California, United States

Requisition #:

19000NPA

Post Date:

Dec 03, 2019


**Principal Project Engineer - RTG Neurovascular**


Are you a passionate, dedicated and motivated Principal Project Engineer that thrives on directing, organizing, and executing quality projects to improve efficiencies, business continuity and cost?


The **Principal Project Engineer** will actively lead, manage and support improvement projects for the Quality Department in the Neurovascular franchise through use of formal project management and problem solving techniques. You will be responsible for gathering inputs from various functional stakeholders, establishing project milestones and providing updates to leadership. This position also provides technical mentorship, including problem solving and DMAIC and decision-making guidance to other project teams. These projects may include but are not limited to the following: improvement of quality and business processes (pre-market, post-market and quality systems), reduction of product costs and improving customer satisfaction.


**Responsibilities:**


Responsible for managing and supporting development and execution of strategic objectives for the function.

Lead planning efforts for assigned projects to develop project plan, project contract, project risk analysis (including risk mitigations), schedule and budget in conjunction with the project team to achieve the project goals.

Responsible for direct involvement in daily tasks necessary for successful project execution. Helps with problem solving and issue resolution. Helps establish project objectives, timelines, and milestones.

Participate in preparation for internal and external Quality system inspections and implementation of Quality system changes.

Manage projects and diverse groups of individuals at different levels within or outside the organization.

Facilitate effective communications with project team, support team and management. This includes timely, unbiased communication of project status and issues.

Manage project execution to achieve project plan/contract. Proactively address issues to minimize their impact to project.

Proactively address any performance issues on the project team with the individual and their manager in a timely manner. Provide team members feedback on their performance.

Conduct Project updates with Management in a professional and unbiased manner.

Works with very little direction towards predetermined long-range goals and objectives. Assignments are often self-initiated.

Proficient at a systematic critical thinking method that yields consistent results.

Identifies problems: Keeps the organization informed of existing areas for improvement, maintains focus on and gives visibility to related improvement actions; and identifies potential new/additional improvement opportunities.

Influences functional leaders, project teams, and cross-functional partners to establish mechanisms that drive continuous improvement.

Proactively works in determining process inefficiencies, jams and initiatives and areas that meet overall business and functional strategic goals.

Able to lead/govern projects simultaneously with excellent prioritization and project risk evaluation skills in addition to resolving ambiguity.

Proven ability in coach and influence project teams to achieve maximum performance and efficiency in the project.

Partner and/or support initiatives to maintain and improve quality system and its effectiveness, business process improvements; participate in group and/or corporate projects as needed.

Provide problem solving and DMAIC support, mentorship and facilitation to projects teams including CAPA, internal audit and quality projects.


Do meaningful work, make a difference, and improve lives starting with your own.


**Medtronics 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.


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.


**_Come for a job. Stay for a career._**


**Must Have: Minimum Requirements (Must be evident on the resume)**


Bachelors degree

7+ years of relevant experience with Bachelors degree/ 5+ years of relevant experience with a Masters 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.

Masters 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.

**Medtronics 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.


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.


**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. Lets 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._**
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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Posted: 2019-12-05 Expires: 2020-02-09

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Principal Project Engineer Neurovascular

Medtronic
Irvine, CA 92604

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