Job Information
Medtronic Pre-Market Quality Engineering Director- Mounds View, MN in Mounds View, Minnesota
In this exciting role as a Pre-Market Quality Engineering Director, you will be responsible for leading Quality Core Team Members (QCTM) within the Cardiac Rhythm Management (CRM) Operating Unit. You will have leadership responsibility for developing and managing the CRM Pre-Market Quality Strategy, and overseeing resource allocation for development programs. This includes setting and implementing the strategic direction and vision for the QCTM staff and CRM pre-market quality. Additionally, you will be responsible for effectively resourcing and partnering with development to deliver new, innovative products to the market, and building a high performing work team. This position will have great visibility across the CRM Operating Unit and the Cardiac Implantables Technology Development Center.
CVG
The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one 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. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in The Life:
The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports.
A key responsibility of roles in this career stream is managing people, which includes:
Accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives
Providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets
Conducting performance reviews
Staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals
Additional responsibilities include:
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.
Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Must Have: Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident on your resume
BS Degree in Engineering, Science, or technical field
10 years of relevant experience in Product Development, Quality or Engineering with 7+ years of managerial/leadership experience, OR advanced degree with 8 years of relevant experience in Product Development, Quality or Engineering with 7+ years of managerial/leadership experience
Project management experience in a leadership capacity with in-depth knowledge of the product development phase review process in the medical industry.
Prior medical device experience
Nice to Have
Engineering or science related background/experience
Experience working within a regulated environment
Experience working with pharmaceuticals
Senior level knowledge of quality management, quality operations, and quality engineering industry best practices
Knowledge and understanding of quality standards per ISO 13485, MDD, CMDR, and FDA 21 CFR 820 applicable standards
Knowledge and understanding of the risk management process and requirements of ISO 14971
Excellent influential and collaboration skills
Knowledge and understanding of reliability engineering principles and best practices
Knowledge and understanding of product development processes
Experience working in Operations or Operations Quality
Experience defining, driving, and implementing process improvement and functional excellence efforts
DRM, Lean Sigma, Six Sigma, Professional Engineer, and/or Reliability Engineer Certification
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. Let’s 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here .
EEO: 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 .
Min Salary
176800
Max Salary
265500
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.