Senior Project Engineer

CPL

Limerick

Senior Project Engineer (EU MDR Project, Temp 12months. Summary. The Senior Project Engineer is responsible for maintaining the design files and manufacturing a portfolio of material products with the Craniomaxillofacial division. This role will assess and implement design and process changes/improvements to the product technical files, ensuring compliance of client products in accordance with relevant regulatory requirements and standards for medical devices. This individual contributor needs to frequently Interface with cross-functional counterparts (Manufacturing, Quality, Regulatory, etc.) across a variety of sites in order to maintain the biomaterial product portfolio. The role requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision. Your key responsibilities. Will work within the R&D team, under minimal supervision, with responsibility for EU MDR related activities, including, but not limited to the following: Actively interfacing with cross-functional team members and third-party vendors, and always practicing good teamwork in support of achieving the business targets. Proficient in risk management practices and tools. Develop and provide input for risk management by identifying opportunities and weaknesses. Collaborate with project leadership to create project plans; identify and allocation of activities between internal and external resources and assign work. accordingly. Collaborate with project stakeholders identification of EU-MDR deliverables. Understand MDR impacts to assigned product portfolio and communicate. to team members accordingly. Coordinate priorities with other EU MDR workstreams to feed into the. the overall success of the EU MDR program. Communicate MDR project implementation options, schedule, quality, and. risk with project lead, as well as offer recommendations based on these. Responsible for the creation, review, and update of EU MDR-related documentation and activities. Responsible implementation of resultant changes through the change management system. Responsible for conducting a Gap assessment as per current risk. management documentation & trace matrices against new EU MDR. Standards. Excellent Communication & Interpersonal skills in coordinating, project. planning, scheduling, tracking, and interaction with cross-functional teams, What are we looking for? Bachelor's degree in biomedical engineering or LiveScience degree (or related discipline), with a minimum of 2 years experience. Proven Project Management skills through the delivery of business-critical projects. Experience in highly regulated industries. Be a positive, energetic team player, and an advocate for product excellence and quality. Proven to be self-directed, self-motivated, and able to prioritize and resolve competing priorities. Strong organizational, interpersonal, communication, and influencing skills in order to effectively interact with diverse, cross-functional internal and external agents. Capable of working as part of a multi-disciplined team in a dynamic and results motivated environment. Excellent presentation and written / verbal communication skills. Demonstrable ability to work autonomously. High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, Visio, and PowerPoint packages. Familiarity with ISO 13485, GDP, GMP desirable. Excellent English (both oral and written. Hands-on experience in documentation such as gap assessments, protocols & test reports. Hands-on experience in creating risk management documents. Knowledge in ISO13485 / EUMDR / 21CFR regulations.

1023 days ago