Senior Mechanical Engineer

Our Client, an Irish Medical Device Developer which is currently at a really exciting stage in the product life cycle, is looking for a Senior Mechanical Engineer to join their team. Reporting to the Director of Operations, this candidate will be involved in software and hardware development, as well as testing and validation processes. The successful candidate will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept work through to commercial release. Responsibilities include but are not limited to: Work closely with Project Lead and Product Development team to develop, build and test next generation medical devices. Support product development from concept generation through to post-production. Manage and update specifications/ drawings and initiate ECO's in support of Sustaining Engineering and Operational needs. Support design and technology transfer from product development to manufacturing by proactively working with stakeholders from manufacturing and quality. Leading process development and process validation activities, including IQ, OQ & PQ. Liaise with the manufacturing team and external suppliers on an ongoing basis during the development stages to guide DFM activities. Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions. Participation in the drafting of test protocols may be required, in addition to documenting test results and generating test reports. Testing may include mechanical, electrical, performance, user interface / usability and software. Perform necessary design activities through utilization of 3D and 2D CAD software. Analyze and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems. Report writing and preparing presentations to communicate findings. Provide coaching and mentorship to other members of the Engineering Team. Degree in Mechanical Engineering, Manufacturing Engineering or similar discipline.  5+ years' medical device industry experience in a product development or manufacturing role. Product design and development experience, including experience in design review, risk management and quality procedures. Proficient in using Solid Works, Inventor or equivalent 3D CAD design package. PC Literate (word processing, spreadsheets, data base) and a good knowledge of project management tools. A good understanding of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA quality system regulation processes according to 21 CFR part 820 and EU MDR. A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc. Experience in the development of test methods and associated product testing. Excellent analytical skills, ability to plan, organize and implement multiple concurrent tasks. Ability to present ideas and concepts clearly and effectively to all levels of the company. Excellent planning and coordination skills and capable of initiating and leading change. Willingness to travel internationally as required. Desirable skills and knowledge : analytical problem solving skills; understanding of lean principles ; proven track record for identifying and implementing improvements to processes and mitigate risks, knowledge of international safety standards i.e IEC60601, ISO14971 and 10993; experience in statistical principles and software such as R, STATA or Minitab; Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies. Pale Blue Dot Recruitment -  The Resource for the MedTech Workforce