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Katalyst Healthcares and Life Sciences

Sr. Manufacturing Engineer Job at Katalyst Healthcares and Life Sciences in Syra

Katalyst Healthcares and Life Sciences, Syracuse, NY, United States


Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Lead and facilitate design / specification, purchase, installation and qualification of mold tools, moulding's machines, ancillary equipment, and service requirements for their installation. Understand the business needs of the company and have a thorough understanding of customer and clinical needs as they relate to projects. Demonstrate strong and clear accountability / responsibility for success and timely. completion of designated project deliverables. Design and lead complex experiments, often with multiple variables; independently execute and/or direct others in the execution of project tasks by applying Client engineering theories, concepts, and techniques. Working closely with the project team and third-party manufacturers to ensure required support is provided to meet project objectives. Work closely with all key stakeholders to develop metrology methods. Conceptualize complete solutions; create or coordinate the design solutions for Client or complex problems; explore multiple alternatives. Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies; may coordinate technical matters between organizations. Responsible for completing documentation in a timely manner and in accordance with business standards. Other tasks and duties as assigned. Understand and comply with applicable EHS policies, procedures, rules and regulations. Responsible for implementing and maintaining the effectiveness of the Quality System. Requirements: Bachelor's degree (preferably in Polymer Engineering, Polymer science) or a closely related discipline is desired) or equivalent technical experience and demonstrated competence required; additional post-graduate education may contribute toward the desired years of experience. Typically requires 8+ years of significant engineering and / or operational experience to develop the competence required to meet the skills and responsibilities of the position. Candidates / incumbents should possess the following: Expertise in Plastic injection mounding technologies, Mold tool designs and process Development in third-party manufacturing environment. Effective communication, presentation, and documentation skills. Problem analysis, fault finding on injection Mold tools and equipment. Design of Experiment for plastic injection moulding process development. Structured and controlled working practices with clear and accurate documentation, reporting and presentation skills. Good level of engineering, validation, and process development knowledge. Risk analysis with sound understanding of FMEA process. bility or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. bility to form and develop interpersonal, professional relationships; display socially and professionally appropriate behaviour. Strong understanding GD&T and design of metrology fixtures. bility to work independently and in groups; ability to work cross-functionally. bility and aptitude to use various types of databases and other computer software. Strong organizational and project management skills in third-party manufacturing environment. bility to quickly gain knowledge, understanding or skills and is willing to learn. Prior Experience of analyzing First Article Inspection (FAI) and process capability data . Experience in work with tooling manufacturing sites including interacting with toolmakers suppliers for design & FAT qualification activities. Familiarity with cGMP, FDA and ISO regulated environment. Experience with instrumentation moulding for process control would be an advantage.