Engineer II, Mechanical

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.

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