Senior Design Quality Engineer - Respiratory Interventions

The Design Quality Engineer position is one of development, improvement and innovation, if you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Airways group. Facilitate the application of design controls and Change Control processes in product development and sustaining changes. Also providing support in the rapid resolution of product complaints and/or safety issues. As our Senior Design Quality engineer, your Key Accountabilities will involve: • Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. • Review and implement changes to corporate methods and procedures. • Ensure that product development projects and changes to existing products are conducted in compliance with Medtronic’s QMS, ISO13485, EU-MDR and the FDA Quality System Regulations. • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report). • Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance. • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Skills & Qualifications: Minimum requirements: • BSc [Bachelor’s Degree] Mechanical engineering, Quality Management or related disciplines • 5 years’ experience in the Medical Device Industry or a similar role • Good verbal and written communication skills through English, including protocol / report development and technical presentations. • Experience in ISO 13485 • Experience in Risk Management ISO 14971 • Experience of EU-MDR regulations. • Experience of verification/validation test plan development and root cause failure analysis. Preferred requirements: • Familiar with statistical software tools (Minitab, Stat Graphics, Statistical), Desirable • Stability, Biocompatibility, Sterilization, Transportation Testing Knowledge, Desirable Other Skills: • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis. Desirable • Computer literate and experience with PCs, networks, and applications • DFSS Green Belt or Black Belt Desirable • Familiar with DMAIC or DMADV(DFSS) methodologies Desirable • Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable Preferred locations: Mirandola Italy or Athlone Ireland. Notes: Travel will be required as part of the job with an estimate of 5-10% travel requirement. The sucessful candidate will have primary responsibility for products manufactured at our sites in Mirandola Italy and Neustadt, Germany but support of our world wide opperations will / may also be required. The role can be completed remotly [working from home]. 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) Additional Information Posting Date: Nov 6, 2020 Travel: Yes, < 25 % of the Time ...