Design and Development Engineer III

14 hours ago

Wolcott, Connecticut, United States Nissha Medical Technologies Full time
Job Title: Design and Development Engineer III

Nissha Medical Technologies is seeking a highly skilled Design and Development Engineer III to join our team in Wolcott, CT. As a key member of our engineering team, you will be responsible for designing and developing product solutions that meet customer requirements.

Key Responsibilities:
  • Develop product specifications derived from customer requirements
  • Conceptualize new product solutions that meet customer requirements
  • Perform engineering analysis to verify product concepts
  • Design and develop product solutions, including CAD modeling, design for manufacturability, and material selection
  • Develop detailed drawings of components and assemblies
  • 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 product designs
  • Design and procure/fabricate test fixtures
  • Prepare protocols and reports of various types
  • Develop procedures and instructions for assembling product designs
  • Specify or modify production processing equipment required for manufacturing products
  • 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 product designs
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
  • 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 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
  • Ability to perform testing, collect data, and analyze data is required
Preferred Qualifications:
  • MS Word-required
  • MS Powerpoint-required
  • MS Excel-required
  • Minitab-required
  • Solidworks-required
  • Marc/Mentat or Similar CAE Software-preferred
What We Offer:

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status.

In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.

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