Senior Design Assurance Engineer - SH&A
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
Within our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support across all aspects of PDP from premarket product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the Structural Heart devices we develop, is assured, and maintained throughout the product lifecycle.
Come for a job, stay for a career!
A Day in The Life Of:
* You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.
* You will lead strategies for test method validations, design verification and shelf-life protocols / reports.
* You will be responsible for keeping abreast of industry best practice with respect to product design.
* You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
* You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.
* You will be required to provide Quality input into new product development, process improvements and change control.
* As required, you will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to standard requirements.
* Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Key Skills & Experience
* Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science) and with a minimum of 4 years relevant experience.
* You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
* You are experienced to a competent level within Medical Device product design.
* Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions are a must.
* Excellent communication and ability to influence is critical to the role.
* You must be fluent in English, both in writing and speaking.
* The role is a day shift role. Flexibility to travel <10% of time desirable.
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 90,000+ passionate people.
Who We Are
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.
What We Do
We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people.
How We Are Different
These commitments set our team apart from the rest:
Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life.
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.
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