JWR Employment Specialists are recruiting a Process Development Engineer for a Medical Device manufacturing company located in Boyle.
The Process Development Engineer will be responsible for managing projects and the identification, specification, introduction, management and validation of new equipment, processes, products and technologies.
They will provide technical input and leadership on problem solving, resolution of technical processing issues and implement process improvements.
The role will offer an attractive salary and benefits.
Duties include; Manage, develop and validate new process including running trials/feasibility studies for new product /product iterations and new technology to demonstrate capability and achieve key project deliverables (Cpk, cycle times, lead-time, GM% etc.
)Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentationUses a science-based approach to develop processes, process improvements and technology improvementsUnderstand current processes, taking a hands-on approach to understanding how these can be applied to new opportunitiesWork with equipment and material vendors to mutually understand their and our technical process challenges, to improve capability and eliminate costPrepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costsWrite and review new customer development proposals for development projectsIdentify, develop and implement plans for continuous improvement activitiesLead improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principalsComplete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485, The Medical Device Regulation and FDA Quality System RegulationsAssess customer's validation needs and propose innovative solutionsSupport teams to identify and specify new technology/tooling/materials requiredSkills and Qualifications: Degree in a relevant engineering, science or an equivalent discipline3+ year's work experience in industry, Medical device or manufacturing experience is essentialA Practical level-headed individual with strong technical abilityAbility to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issuesProject management skills, setting realistic objectivesEnergetic and driven self-starter, with good communication and influencing skills
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