At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Careers That Change Lives
A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Sr Engineering Manager - Pre-Market Quality you will have responsibility for the Risk Management and Design Assurance team supporting new product development, research and technology projects in Neuromodulation.
Responsibilities may include the following and other duties may be assigned.
* Plans, directs and implements all aspects of the company's 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 delivery.
* Selects, develops and evaluates personnel to ensure the efficient operation of the function.
* Champion change management to realize global pre-market quality vision and a quality culture
* Develop team capabilities in design assurance and risk management engineering
* Accountable for new product quality and safety functional deliverables and metrics
* Identify product quality and safety issues and drive to resolution
* Manage functional resources and cost center to support annual operating plan
* Work closely with post-market Risk Management and Reliability resources to ensure consistency in documentation between pre-market and post-market teams
* Collaborate with Medical Safety, Pre- and Post-Market Quality. Design, Clinical & Regulatory Affairs, Training, and Quality Systems to ensure appropriate integration of a lifecycle risk management framework
* Collaborate with enterprise Risk Management Quality Center of Expertise (COE) and other Operating Units on strategies and practices
* Travel requirement: Less than 10%
Must Have: Minimum Requirements
(To be considered for this role, please ensure the minimum requirements are evident on your resume.)
* Bachelor's degree in engineering, Science or technical field with a minimum of 7 years of experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of managerial experience.
* Or Advanced degree with a minimum of 5 years of experience in Engineering, Quality, and/or experience in a regulated industry with 5+ years of managerial experience.
Nice to Have
* Medical device functional management experience
* Experience in a development quality role (Ex: safety, risk management, reliability, or design assurance engineering)
* Experience in product development of mechanical, electrical, or embedded systems
* Experience executing and implementing ISO 14971, ISO 13485, and 21 CFR Part 820
* Working knowledge of statistical methods
* Demonstrated influence management and critical thinking
* Ability to work collaboratively to achieve objectives
* Strong written and oral communication skills
* Passion to provide superior products for patients with neurological disorders and diseases
* Strong Knowledge of Quality System Regulations
Physical Job 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 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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$160,000.00 - $240,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.
At Medtronic, most positions are posted on our career site for 3-7 days.
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