Work Schedule

Environmental Conditions

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.

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