Nissha Medical technologies is looking for a Design & Development Engineer III to join our Wolcott, CT. Team!

This position will provide high level technical contribution to the design and development of product solutions based on the design inputs provided by the customer requirements. These product solutions may be systems that are mechanically or electro-mechanically based. The design process utilized shall be in compliance with Quality System and standard operating procedures of Nissha Medical Technologies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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 ensure product quality.
• Identify suppliers of components and procure/fabricate 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.
• Design and procure/fabricate test fixtures.
• 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.
• Conduct process characterization to determine limits of assembly.
• 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:

• Bachelor’s Degree in an Engineering Discipline (preferably Mechanical, Biomedical, or Aeronautical) or 15 years of relevant experience
• 5 to 8 years of Design related experience is preferred
• Communication Skills, specifically the ability to convey technical information effectively in both verbal and written medium
• Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is required.
• Has experience designing disposable multicomponent mechanical systems with between 15-50 components
• Basic understanding of 21 CFR 820, ISO 13485, and ISO 14971 is required.
• Thorough understanding of the fundamental principles of Design Control, Document Control, and Process Control/ Validation is required.
• Working knowledge of Engineering Statistics is required.
• Engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
• Thorough understanding of Plastics and Metals including processes for manufacturing these components for the healthcare industry is required, i.e. designing parts for injection molding, or designing parts for progressive stamping.
• Understanding of the fundamentals of Finite Element analysis is preferred.
• Understanding of the basic principles of tolerance analysis including form, fit, and functional stack-ups are required. Understanding of Monte Carlo Simulation is preferred.
• Understanding basic methods of inspection is required.
• 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.
• Computer Skills
  • MS Word-required
  • MS Powerpoint-required
  • MS Excel-required
  • Minitab-required
  • Solidworks-required
  • MathCAD-preferred
  • Marc/Mentat or Similar CAE Software-preferred
• Ability to perform all assigned tasks, work independently and complete work on schedule.
• Follow directions wile displaying cooperative and positive behavior with co-workers.
• Strong problem-solving skills and efficient management of time and resources.