Senior Process Development Engineer

1 month ago

Galway, Ireland Medtronic Vascular Galway UC Full time

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 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 Our Galway based New Production Introduction teams focus on the development of cutting-edge medical devices in the Coronary, Structural Heart, PVH, Cardiac Rhythm Management and Neuromodulation space. Our Process Development Engineers are directly involved in working on the development of innovative products for use in medical procedures. Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulation (SCS) to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat disorders such as Parkinson's disease. We have gone on to develop the first implantable drug pump for the delivery of medication directly to the intrathecal space of the spine, inventing the first balloon kyphoplasty devices for the treatment of vertebral compression fractures and developing RF ablation systems to treat spinal tumors. A Day in The Life Of: Within Medtronic Neuromodulation, one key area of focus for reducing pain for patients is Interventional Pain. Interventional Pain develops minimally invasive therapies that treat musculoskeletal pathologies such as vertebral compression fractures, nerve pain, metastatic and benign bone tumors. The employee will be part of the Operations New Product Introduction team based in Minnesota and co-located with the R&D Team in Galway to define, develop and test new products for the Neuromodulation business. Employee responsibilities may include the following: As a member of our team, you will actively participate in all areas of new product development including the following: Process design, Supplier selection, Sub Tier supplier management & Project management. Provide leadership to process development activities and Design transfer on multiple R&D projects. Effectively lead process development/validation activities with Contract Manufacturer to setup robust processes in place. Effectively lead process development activities with Medtronic Distribution centers to setup processes in place. Research technology solutions and collaborate with team members on Design, Reliability & Manufacturability methodology (DRM), utilize 3-D drawing/printing and Augmented Reality to develop our best solutions that will allow us manufacture devices that will positively impact the healthcare of millions. Collaborate with cross functional teams to define, execute and deliver on New Product Development requirements. Take initiative & lead a team to innovate and develop best in class process technology with emphasis on improving quality, reducing variation and developing state of the art automated and semi-automated systems. Lead and support the process development, characterization, and validation activities to support new product introduction. Identify and carry out practical actions to solve technical problems using your new and existing skills in project management, six sigma tools, process characterization and technology development. Collaborate, document, and present all learnings to project and functional teams. Participate in design and development activities like tolerance stack analysis, failure analysis, new risk (FMEAs etc) Represent manufacturability input on engineering drawings. Align on new/revalidation activities with the contract manufacturer Responsible for all the manufacturing and operation related activities like IQ/OQ/PQ, control plans, Co-suppliers documents and precision, MSA (inspection methods), AQL quantity, process flow, manufacturing protocols ) DTP (design transfer plan) GQF127 (capture all the validation activities /control plans) DTC (design transfer confirmation) QAC ( quality assurance condition document) FAI (FAI at our contract manufacturing end) DMR (design of manufacturing records) Key Skills & Experience Level 8 Degree in Engineering / Science or related discipline with minimum 4 years relevant direct engineering experience. We are looking for a self-driven engineer who can provide leadership to process development activities. Experience in Design transfer/Process Validation Experience working with contract manufacturers Experience in Design for Manufacturability assessment and early phase engagement leading up to concept selection. Strong knowledge and hands on experience in process characterization/development. Knowledge of statistical methods and design of experiments (DoE) We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams and on various R&D projects with strong attention to detail. Ability to clearly document work, articulate and present ideas and tests results to a variety of audiences. We are looking for a good communicator and fluency in English, both in writing and speaking. Medical device industry experience. Nice to Have Knowledge of plastics injection molding process and evaluating design for injection molding Experience taking products from concept through launch DRM certification Medtronic offer a competitive salary and flexible Benefits Package #IJ 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 90,000+ 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. To start the process click the Apply button below to Login/Register.

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