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1+ months

Engineering Manager

Irvine, CA 92604
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Engineering Manager


Irvine, California, United States

Requisition #:


Post Date:

Nov 22, 2021

**Careers That Change Lives**

What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes.

The **Neuroscience Portfolio** provides innovative, life changing restorative therapies and services to meet the needs of people worldwide who suffer from a wide range of chronic medical conditions. The **Neurovascular** businesses develop products and procedural solutions for surgical applications which include brain and stroke therapy solutions.

In this exciting role as a **Quality Engineering Manager,** you will have responsibility for managing a group of exceptionally capable and diverse Design Quality Engineers. These engineers support sustaining RD projects and broader Quality Engineering initiatives.

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

+ Plans, directs and implements all aspects of the companys design and development of new medical device products or software systems.

+ May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

+ Oversees the investigation and evaluation of existing technologies.

+ Guides the conceptualization of new methodologies, materials, machines, processes or products.

+ Directs the development of new concepts from initial design to market release.

+ Manages feasibility studies of the design to determine if capable of functioning as intended.

+ Monitors documentation maintenance throughout all phases of research and development.

+ Organizes the coordination of activities with outside suppliers and consultants to ensure timely

+ Collaborates with RD, Regulatory, Operations, and Process Engineering to ensure high reliability and safety for NV products, and compliance to NVs Quality system procedures.

+ Implements and validate methods and procedures for inspections and Validation testing.

+ Performs statistical analysis to support quality decisions.

+ Support CAPA and NCR dispositions. Support Field Corrective Actions and product holds. Support Issue Investigations across Released Product Engineering. Support Remediation projects and Design and Process changes.

+ Create ,Maintain, and implement Risk Management processes across products and processes

**Qualifications - External**

**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**

Bachelors Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ year of work experience in Engineering, Quality, and/or experience in a regulated industry.

**Nice to Have**

+ Prior experience in medical device design quality

+ Strong Technical experience.

+ Strong TM development and Validation skills/experience.

+ Prior supervisory role (managing engineers)

+ Working Knowledge of medical device regulatory laws and standards

+ Experience with inspection plans and inspection tools/equipment qualification

+ Six sigma certification / ASQ certifications

+ Experience managing product nonconformance (disposition, rework, closure)

+ Experience with QAD SAP enterprise resource planning systems

**About Medtronic**

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. Lets 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)
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.


Posted: 2022-03-08 Expires: 2022-06-06
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