Job Description
Senior Manufacturing Engineer (Remote)Our client, a US-based startup medical device company that has established a technical operations group in Ireland, is currently seeking a Senior Manufacturing Engineer to join their team. Reporting to the VP of Technical Operations, the Senior Manufacturing Engineer is responsible for leading Manufacturing Engineering activities, including activities at contract manufacturing suppliers and distribution centers. The role is primarily remote but will require travel as needed to the main contract manufacturer based in the West of Ireland.Role/Responsibilities:Directly manage Manufacturing & Project activity at contract manufacturing organizations, including product builds, product quality issue resolution, process development, technical training, validation, and continuous monitoring of manufacturing performance.Provide technical leadership for 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 Balance.Work with Quality, including management of NCMRs and CAPAs, 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 the company’s long-term manufacturing and distribution channels.Develop and execute commercial manufacturing timelines consistent with project and regulatory needs.Conduct financial modeling for COGS and scaling up production capacity.Facilitate technology transfer to partner or contract manufacturing organizations, as applicable.Promote and support a continuous improvement culture and drive cost-saving initiatives.Create and manage the annual budget for Manufacturing project activities.Provide strong integrity, vision, knowledge, and overall aptitude to the organization.Skills/Experience:Bachelor’s degree in Engineering or related specialty.A minimum of 7 years’ experience, with at least 3 years in a technical leadership role in the biotechnology, pharmaceutical, or medical device industry.Experience working within ISO 13485/FDA regulated quality systems.A proven track record in manufacturing and process development in a regulated environment. Medical device catheter product experience is a plus.Ability to achieve results in a virtual organization, with experience working with cross-functional teams and demonstrated ability to complete projects on time.Well-versed in both Manufacturing and Product Development Processes, including Risk Management and KPIs.This role is primarily technical in nature; thus, we seek someone who is passionate about Engineering concepts and principles.A 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.Understanding and application of risk management methodology.Excellent analytical and decision-making skills.Possess a flexible, pro-active approach to problem-solving, be an adept negotiator, and apply risk-based decisions.Ability to develop and maintain strong collaborative relationships with all functional departments of the organization.Strong organizational, communication, interpersonal, managerial, and leadership skills.Ability to effectively and efficiently manage consultants, suppliers, vendors, and budgets.Ability to work in a fast-paced, high-growth environment and handle multiple tasks with high quality and timeliness standards.For further information, please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence at 086 0204322. #J-18808-Ljbffr