Sr R&D Engineer II

Job Summary: The Senior Engineer II - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of medical device manufacturing process. This position will represent Manufacturing Engineering on multi-discipline project teams implementing new products, production support, process improvements, or manufacturing transfers. In this role, the Manufacturing Engineer serves as the subject matter expert (SME) and mentor for junior staff in the manufacturing processes they are assigned to. Salary range: $134,100 - $201,100 Job Details: Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned production processes and related business continuity needs. Troubleshoot and provide guidance on manufacturing process and equipment. Work with Quality Engineering and Production personnel in the conduct of root cause analyses of process non-conformances and implementation of corrective actions. Provide manufacturing engineering leadership and expertise to the identification, execution and implementation of performance and cost reduction continuous improvement opportunities of assigned production process. Utilize tools such Gage R&R, Cp, Cap, and SPC to improve processes. Implement manufacturing concepts like Value Stream mapping, 5S and lean manufacturing and Visual Workplace to improve quality, labor efficiency, and throughput. Provide technical expertise and leadership to the design, fabrication, development, process characterization and analysis, and process validation activities of equipment/processes including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Actively lead and participate in the performance of formal process validations to ensure their compliance to validation protocols. Ensure all protocols and validation reports are correct and well-written Provide mentorship and guidance to lower-level engineers and technicians to assist in completion of technical work and to develop their technical knowledge and engineering skillset. Assign, delegate, and monitor the completion of engineering tasks or projects to lower-level engineers. Investigate, recommend, and implement manufacturing process improvements. Provide assistance to production as required. Comply with FDA (US) and PMDA(Japan) Quality System Regulations, and ISO 13485 requirements, ISO 14971, Company policies, operating procedures, processes, and task assignments. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements. Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition. Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience. Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement. Develop and maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Perform other job related duties assigned. Knowledge, Skills and Abilities (KSAs) Demonstrated ability to design, specify, assemble and validate manufacturing equipment and processes. Demonstrated ability in the use of critical thinking, problem solving and analysis. Working knowledge of Statistical Process Control (SPC), Six Sigma principals and problem solving and decision-making tools. Effective communication skills, both verbal and written.Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to US and notified bodies. Knowledge working under quality systems designed to meet governmental regulations such as 21 CFR 820, and PMDA MO. 169, ISO 13485 and ISO 14971 and additional knowledge of EU MDR 2017/745 is a plus. Background Experiences BS in Mechanical, Electrical, or similar engineering discipline from an accredited university or college with 12 or more years of working experience with increasing responsibility in Manufacturing and Process Development in the medical device field advanced degree in Engineering preferred Career progression of increasing responsibility and experience in Manufacturing Engineering, Process Development, and/or Automation Engineering. Experience in an FDA regulated industry, medical device or pharmaceutical preferred Experience in a manufacturing environment for designing, specifying, assembling, and validating manufacturing equipment and processes. Hands-on experience with manufacturing equipment ranging from manual to fully automated preferred. Experience working with Design control procedures and requirements, including risk management. Effective use of MS Office Suite.