- Communication Skills
- Computer Skills
- Microsoft Office
Biomedical Innovations, a division of Nissha Medial Technologies, a leader in contract manufacturing of finished consumable medical devices has a current opportunity for a Design Engineer in our Wolcott, CT Innovation Center.
The main focus of the job is to 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 electromechanical based.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Essential Duties & Responsibilities Include the Following:
Conceptualize new product solutions that are capable of meeting customer requirements based on product specifications.
Develop product specifications derived from customer requirements.
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.
Perform initial engineering builds of design prototypes.
Perform prototype evaluations.
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.
Required Skills & Qualifications:
Communication Skills, specifically the ability to convey technical information effectively in both verbal and written medium
Computer Skills including, MS Office, Minitab, SolidWorks, Arena, MathCAD, Creo/Pro Engineer, Marc/Mentat and Oracle
Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is required.
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.
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.
Ability to conceptualize and document creative mechanical solutions to challenging problems are required.
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.
Part of this position requires work to be performed in an engineering lab environment. This environment may have all the hazards associated with an experimental R & D laboratory. Use of PPE is in this environment is expected and is required.
On occasions this job may require product sample evaluations be used in a preclinical laboratory environment. This testing may include animal or human tissue testing. This testing may also include in-vivo lab evaluations.
Educational & Professional Qualifications:
A 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.
Biomedical Innovations is an Equal Opportunity Employer. Biomedical Innovations considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.