Job description
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
In our Coronary and Renal Denervation Design Assurance Team, our purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates.
Come for a job, stay for a career!
A Day in The Life Of:
- Work closely with your Design Assurance team, and cross-functionally with product development engineering, clinical, marketing, and regulatory to translate product specifications into test methods and ensure appropriate test methods are developed & validated for the specific device, clinical use conditions and target patient population, meeting all stakeholders’ requirements.
- Undertake and successfully complete complex test method development tasks including replicating clinical use conditions, adhering to applicable standards, designing, and sourcing fixtures, determining appropriate equipment and equipment qualification, programming test equipment and writing test scripts, and writing clear, concise setup and test procedure instructions.
- Undertake and successfully complete complex test method validation tasks including operator training, determining appropriate validation study design and sample size, data analysis including crossed gage R&R, ANOVA, Probability of Misclassification, identification, and reduction of sources of variation and report writing.
- Liaise with extended team members, test lab managers and test operators, to facilitate timely completion of test method development and validation activities in alignment with the overall project phase and project target milestones.
- As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
- Work independently to plan and schedule own activities necessary to meet timelines.
Key Skills & Experience
- We are looking for a person qualified to Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science), with 2+ years of experience in Engineering, Quality.
- Experience in the management of complex data sets and statistical data analysis.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
- Collaborates and Creates Alignment, Thinks Critically and Makes Sound Decisions.
- May have practical knowledge of project management.
Perks and benefits
- Health & Well-Being
- Financial Future
- Learning & Development
- Volunteer & Giving
- Hybrid Work Model
Medtronic offer a competitive salary and flexible Benefits Package
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