Sr Process Development Engineer

3 weeks ago

New York, United States Terumo Medical Corporation Full time

Job Summary The Sr Engineer I - Process Development Engineering position is responsible for providing advanced engineering support to existing product process transfer projects at site or at contract manufacturer, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development requirements in accordance with Terumo processes and procedures. Job Details/Responsibilities Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control, design control requirements, early manufacturing activities including but not limited manufacturing builds, documentation creation/support and nonconformances. Participate in and provide manufacturability insight and guidance to the design and development of new products to facilitate the development of viable production processes for the products under development including supplier engagement, material procurement and appropriate testing. Serve as a Process Leader for the development or transfer of production processes. Accountable for the execution of all engineering activities required to develop, implement, and validate processes under development or modification. The Process Leader “owns”” the big picture of the production process and ensures that its overall performance and validation requirements are achieved. 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. Install production/process equipment and support the conduct of Installation Qualification (IQ), Operational Qualification (OQ), formal PQ validation activities and the documentation of their results. As required, serve as a Problem Solver to product and process issues and apply the proper engineering tools and techniques for their resolution and implementation of any required process modifications. Participate in and contribute to project team meetings, Design Reviews and other formal project reviews. 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. Performs other job-related duties assigned.

Working Conditions/Physical Requirements This position will be located in the TBAIL facility in Campbell CA. The position will perform required duties in an office environment, the Laboratory area, and within manufacturing areas. Knowledge, Skills and Abilities (KSA) Engineering position, candidates should possess the following KSA’s: Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements. Preferred: Catheter process development or manufacturing experience Experience in the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools. Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines. Demonstrated strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes. Demonstrated ability in the design, development and implementation through production qualification of a new or novel medical device production process. 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 the FDA. 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. Ability to work in drafting programs such as SolidWorks Effective use of MS Office Suite.

Qualifications/ Background Experiences BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.

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