Engineer II, Mechanical

3 days ago

Asheville, United States Thermo Fisher Scientific Full time

Work Schedule Other Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 275 Aiken Road, Asheville, NC 28804 TITLE: Engineer II, Mechanical HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: • Develop specifications for system-level, subsystem and component performance based on customer needs and product requirements. • Develop the optimal design through Computer Aided Engineering (CAE), Finite element analysis (FEA), Tradeoff Analysis, Technology Assessment, Failure Modes and Effects Analysis (FMEA). • Develop and execute test plans to validate the performance of newly developed products by utilizing design for reliability tools and performance sensitivity analysis. • Support manufacturing to evaluate and troubleshoot issues and recommend solutions to maintain production uptime. • Work with Regulatory Affairs team members to design products that meet and acquire the required global product approvals and certifications such as, FDA, UL, CE, CSA, NSF, and Energy Star. • Identify and implement design changes that improve user experience, quality, manufacturability, serviceability and sustainability of CTT products. • Designing and coordinating with vendors to optimize Design for Manufacturability (DfM). • Detail design, including a strong familiarity with manufacturing techniques and capabilities, internal and external standards, and GD&T. • Participate/lead prototype build of new designs. • Conduct feasibility studies, create prototypes, and perform testing to validate and refine mechanical designs. • Manufacturing processes and materials selection for refrigeration and process temperature control equipment. • Work and collaborate with cross-functional teams in a fast-paced R&D environment in the medical device space. • Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs to optimize mechanical performance and ensure compliance with regulatory standards. • Utilize R&D procedures like design controls and risk management, per the Quality Management System. Travel: Up to 10% domestic travel required. REQUIREMENTS: MINIMUM Education Requirement: Bachelor’s degree in Mechanical Engineering, or related field of study. MINIMUM Experience Requirement: 3 years as a Mechanical Engineer, or related experience. Alternative Education and Experience Requirement: Master’s degree in Mechanical Engineering, or related field of study plus 2 years as a Mechanical Engineer, or related experience. Required knowledge or experience with: • Design, selection, and evaluation of mechanical systems and components used in refrigeration and process temperature control equipment; • Experience in Engineering tools and applications including Excel, Minitab, CAD (SolidWorks preferred), and PLM software; • Regulatory and safety requirements for electrical equipment for measurement, control, and laboratory use, as well as medical device requirements through standards like IEC 61010-1, ISO13485, & ISO14971, FDA, CE, CSA, NSF456, Energy Star; • Coordinating personnel in the implementation of design changes; • Analytical skills, data interpretation and root cause analysis experience; • Project Management experience working with cross-functional teams in matrix organization; and • Quality management systems (QMS) in the medical device industry. #LI-DNI Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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