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 Medtronic At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.
Our Purpose At our Quality Department in Medtronic, plc, we focus on supporting the product value stream to ensure that customer and patient needs are met every day.
Our key focus is on delivering and maintaining a high level of Quality to ensure that business and performance goals are achieved.
The Senior Quality Engineer role is critical in supporting key department metrics thus contributing to the global strategy and to deliver on our mission to contribute to human welfare by supporting the manufacture of products that alleviate pain, restore health, and extend life.
In our Structural Heart Post Market Quality Department, we focus on partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces, while working within the organisation to build, motivate and lead high performance teams.
Come for a job, stay for a career!
A Day in The Life Of: Responsibilities may include the following and other duties may be assigned.
Apply knowledge of design control principles and quality engineering techniques throughout the product development process and the product lifecycle.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Collaborates with complaints team for complex investigations.
Provide Design Assurance support to various OU Sustaining & product Surveillance initiatives.
Review and approve changes to designs and development processes and assess their impact in order to ensure reliability requirements are met.
Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO, and ANSI/AAMI/ISO requirements.
Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques (e.g.
fault tree analysis, failure trending and analysis, reliability forecasting, etc.)
to understand product and process robustness.
Lead cross-functional teams in the preparation of Reliability and Patient Safety Risk Assessments, including issue triages for CAPAs, reliability predictions, Hazard Analysis, etc.
As necessary, proposes changes in design or formulation to improve system and/or process reliability.
Develop master test plans that encompass design verification, design validation, shelf-life requirements and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
Supporting internal and external audits (MDR/MDSAP/FDA etc).
Key Skills & Experience Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
Requires a minimum Level 8 degree in Engineering or other relevant discipline with minimum 4 years' relevant experience.
May have practical knowledge of project management.
Experience in a highly regulated industry, preferably medical devices.
Experience with solving complex issues by interacting with cross functional groups.
Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.
Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation.
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
Excellent communication and ability to influence is critical to the role.
Ability to work independently to plan and schedule own activities necessary to meet timelines.
Medtronic offer a competitive salary and flexible Benefits Package #IJA 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.
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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 95,000+ 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 To be considered for this role you will be redirected to and must complete the application process on our careers page.
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