WHO ARE WE?A start-up based in Ireland and Germany developing cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies. To support our hardware development, we are looking for a Principal Process Development Engineer to join our growing team. This role will require the right person to work on-site with our supplier in Galway 3 days per week.Your role will beThe Principal Process Development & Manufacturing Engineer is responsible for leading Process Development and Manufacturing Engineering activities within the organisation, including activities at contract manufacturing suppliers and distribution centres. You will ensure successful completion of projects and coordination of activities to meet company goals; ensuring compliance to applicable standards and regulations; ensuring world-class manufacturing performance; operating cost-effectively; and identifying areas & driving delivery of projects to achieve continuous improvement. You will collaborate with stakeholders and suppliers to plan for and execute project activity to meet production performance requirements.What you offerTechnical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line BalanceResponsible for working with Quality including management of NCMR’s and CAPA’s, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.Contribute to the successful execution of departmental and company goals.Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.Support business partners by providing technical leadership for company’s long-term manufacturing and distribution channels.Development and execution of commercial manufacturing timelines consistent with project and regulatory needs;Financial modelling for COGS and scaling up production capacity.Technology transfer to partner or contract manufacturing organizations, as applicablePromote and support a continuous improvement culture and drives cost saving initiatives.Create and manage annual budget for Manufacturing project activities.Provide strong integrity, vision, knowledge, and overall aptitude to the organization.EXPERIENCEBachelor’s degree in engineering or related specialty with a minimum of 7 years’ experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry.Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodologyA proven track record in manufacturing and process development in a regulated environment. Medical device catheter product experience a plus.Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time.This role is primarily technical in nature; thus, we seek someone who is passionate about Engineering concepts and principles – someone who gets a thrill from how and why things workA seasoned professional in manufacturing & engineering development with knowledge and skills in some or all of the following: DFM, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (SolidWorks preferred), statistical techniques, process validation and control along with Manufacturing KPIsExcellent analytical and decision-making skillsPossess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisionsStrong organizational, communication, interpersonal, managerial and leadership skillsAbility to effectively and efficiently manage consultants, suppliers, vendors and budgets.Ability to work in a fast paced, high growth environment.WHAT WE OFFERWorking on cutting edge imaging systems to the direct benefit of patients and improving healthcare.Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.A learning environment where you can extend and build upon your skills and interests.Flexible working environment and an international culture as well as offices in Germany and Ireland.
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