The main focus of the job is to provide entry level technical contribution to the design and development of Medical Device product solutions based on the design inputs provided by the customer requirements. These product solutions may be systems that are mechanically or electromechanically based. The design process utilized shall be in compliance with Quality System and standard operating procedures of Biomedical Innovations/Sequel.
ESSENTIAL FUNCTIONS AND BASIC DUTIES:

• Follows all employee guidelines and Quality Systems Regulations (QSR's) as defined by NMT's practices, policies and Standard Operating Procedures (SOP's) to ensure that customer requirements and FDA (or equivalent) regulations are met.
• Demonstrates knowledge and acts in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Develop product specifications derived from customer requirements
• Conceptualize new product solutions that are capable of meeting customer requirements based on product specifications. These solutions may include principles of solid mechanics, fluids mechanics, thermodynamics, and thermal mechanics. These solutions may require integration of electrical and software elements provided by other team members.
• Perform engineering analysis as a means of verifying that product concepts have engineering merit and have a high likelihood of meeting the product specifications.
• Perform detailed design of product solutions including CAD Modeling, Design for Manufacturability and Assembly, Material selection, and Drawing Specifications.
• Develop detailed drawing of components and assemblies identifying critical criteria to insure product quality.
• Identify suppliers of components and procure prototype component samples.
• Perform initial engineering builds of design prototypes.
• Perform prototype evaluations and debug samples as required.
• Develop test methods and procedures for verifying that a design meets the product specifications.
• Prepare protocols and reports of various types included as part of design verification.
• Develop procedures and instructions for assembling product designs.
• Specify or modify production processing equipment required for manufacturing the product.
• Research and develop custom manufacturing processes as required
• Design, fabricate, and verify the installation of assembly fixturing and manufacturing aids.
• Identify, document, and verify critical in-process and final acceptance product quality criteria.
• Verify and validate production equipment, processes, and test methods.
• Support and participate in the risk management process required by the medical device industry
• Support, guide, and train production personnel in learning the process assembly instructions for the product design.
• Supports the maintenance of the Engineering lab space by managing calibration of test equipment, maintaining orderly workspaces, and requisitioning management for procuring required lab materials.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Manages and communicates with customers and suppliers in a professional manner thereby maintaining the company's quality reputation.
• Other duties as assigned.

REQUIREMENTS:

• At a minimum this role requires a Bachelor's Degree in an Engineering Discipline (preferably Mechanical, Biomedical, or Aeronautical).
• 0 to 3 years of Design related experience is preferred but not required. Internship experience will be considered on a case by case basis.
• Computer skills to include Microsoft Word, Powerpoint, Excel and SolidWorks (Required). Minitab, Creo/Pro Engineer, MathCAD and Marc/Mentat or similar CAE Software preferred.
• Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is preferred.
• Has a desire to gain experience designing disposable multicomponent mechanical systems with between 15-50 components
• Working knowledge of Engineering Statistics is preferred.
• Skill in engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
• Basic understanding of Plastics and Metals including processes for manufacturing these components for the healthcare industry is preferred.
• Basic understanding of the fundamentals of Finite Element analysis is preferred.
• Understanding basic methods of inspection is preferred.
• Ability to conceptualize and document creative mechanical solutions to challenging problems are required.
• Physical hand assembly common to the production environment is required for this position.
• Ability to use basic machine shop equipment is required for this position. Use of drill presses, grinding wheels, manual lathes, etc. is a must.
• Ability to perform testing, collect data, and analyze data is required.