Careers that Change Lives
You will be a key member of the Surgical Quality Organization as we develop and commercialize a Surgical Solutions that enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes.
Impact Patient Outcomes.
Do meaningful work, make a difference, and improve lives - starting with your own.
In this exciting role as a Quality Engineering Manager, you will have responsibility for leading a team of Quality Engineers that support new product development across the Surgical Portfolio.
The team will have responsibility for developing the strategies that drive component quality, product quality and continuous improvement.
The Quality Engineering Manager and team shall partner with the new product development stakeholder (internally and externally) to manage product performance and enhance the design and development process.
The Quality Engineering Manager leads the oversight of product development, ensuring conformance to design control, risk management, manufacturing controls and purchasing/supplier in alignment with Medtronic policies, FDA, international requirement, and Quality System Regulations.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy.
Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life
Responsibilities may include the following and other duties may be assigned:
Management a team of Quality Engineers' that are responsible for ensuring delivery of quality deliverables within the new product development process.
Manage performance, develop talent, engagement, and inclusion, communicate business and operational developments, plan, prioritize and/or direct the responsibilities of direct reports.
Responsible for mentoring, developing and coaching staff in alignment with performance expectations and defined objectives.
Ensure appropriate team member assignment, performance goals and targets and conducts performance reviews in alignment with the Surgical and department strategic initiatives.
Develop and maintain monitoring systems to track project and team performance driving the identification and execution of improvement initiatives.
Accountable to the organization and our customers for verifiable results in specific elements of new product development quality.
Provide guidance to team, cross-functional teams of engineers and manufacturing functions to investigate and resolve quality or compliance issues discovered through new product development.
Provide guidance to team members in corrective/preventive actions to resolve quality or compliance issues related to design, manufacturing, supplier or quality management system.
Provide guidance on Design, Reliability and Manufacturability (DRM) principles to drive high product development DRM maturity
Collaborate on decisions impacting program and project build and delivery schedule and leverage available resource skillsets to meet varying demands and tasks.
Drives Put Patients First initiatives in collaboration with cross-functional stakeholders and suppliers where necessary.
Champion improvement initiatives to drive functional excellence and efficiencies within the the quality organization
Must Have:
Minimum Requirements
Bachelors degree required
Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
Expertise in product design methodology, risk management and new product development processes for Medical devices.
Expertise in quality management systems and process development
Strong understanding in the implementation Corrective Action/Preventative Actions.
Previous experience in management or supervisory roles with one or more direct reports.
5+ years in related experience in medical device new product development and/or manufacturing.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD
Nice to Have
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA)
Strong understanding of complex, electro-mechanical, software-controlled devices
Demonstrated ability to work successfully in complex and emerging markets, leveraging interpersonal, communication, and technical skills to optimize results.
Strong understanding of Systems Engineering principles and tools
Strong understanding of or certification in Design for Reliability and Manufacturability (DRM) or related programs
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 .
This position is eligible for a short-term incentive plan.
Learn more about Medtronic Incentive Plan (MIP) on page 6 here .
The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.
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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
(ADA-United States of America)
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