Job Openings >> Principal Design Engineer
Principal Design Engineer
Summary
Title:Principal Design Engineer
ID:1909
Department:Engineering
Location:Wolcott, CT
Description

Job Summary
The main focus of the job is to provide is leadership through example and also to deliver technical outputs in 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.

Professional Qualities
A person in this role has demonstrated a track record of successfully executing and completing design projects from start to finish. This individual has established a reputation both internally and externally of the ability to deliver output to the customer on time, on budget, and of high quality. This individual demonstrates a desire to contribute in significant ways to the success of the organization by improving productivity, managing personal output while simultaneously mentoring young employees in an effort to positively impact the quality and brand of the organization in the marketplace. This individual consistently demonstrates a willingness to go the extra mile by doing whatever is required to insure the project output meets the customer’s expectation and is at the quality level that the customers have come to expect from the Nissha Medical brand. This person demonstrates the ability to manage the customer and the customer’s expectations in a way that enhances the customer’s relationship with Nissha Medical. This quality is measured by the engineer’s ability to maintain positive long standing relationships in spite of difficult circumstances, some of which may or may not be in their control or a direct result of their actions. This person also works synchronously with project managers and the design division management.

Principal Engineer Mandatory Job Duties

  1. To be a technical leader and provide mentorship to younger less experienced engineers
  2. Demonstrate an ability to communicate technical information to the customer through routine reporting and project status reviews
  3. To work together with engineering management to provide support for Design and Development process improvements that will enable divisional growth through scalability
  4. Support and lead product design and development projects using a solid understanding of principles related to Human Factors and Usability
  5. Can provide support for maintaining and managing the Design Control system in compliance with 21 CFR 820 and MDSAP ISO 13485.
  6. Develop product specifications derived from customer requirements
  7. 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.
  8. Perform engineering analysis as a means of verifying that product concepts have engineering merit and have a high likelihood of meeting the product specifications.
  9. Perform detailed design of product solutions including CAD Modeling, Design for Manufacturability and Assembly, Material selection, and Drawing Specifications.
  10. Develop detailed drawing of components and assemblies identifying critical criteria to insure product quality.
  11. Identify suppliers of components and procure prototype component samples.
  12. Perform initial engineering builds of design prototypes.
  13. Perform prototype evaluations and debug samples as required.
  14. Develop test methods and procedures for verifying that a design meets the product specifications.
  15. Prepare protocols and reports of various types included as part of design verification.
  16. Develop procedures and instructions for assembling product designs.
  17. Specify or modify production processing equipment required for manufacturing the product.
  18. Research and develop custom manufacturing processes as required
  19. Design, fabricate, and verify the installation of assembly fixturing and manufacturing aids.
  20. Identify, document, and verify critical in-process and final acceptance product quality criteria.
  21. Verify and validate production equipment, processes, and test methods.
  22. Lead the risk management process required by the medical device industry
  23. Support, guide, and train production personnel in learning the process assembly instructions for the product design.
  24. 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.
  25. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
  26. Manages and communicates with customers and suppliers in a professional manner thereby maintaining the company’s quality reputation.
  27. Develops Master Validation plans including IQ, OQ, PQ, PPQ, and Gage R&Rs. Able to execute process validations as a technical lead.

Educational/ Professional Qualifications

  1. At a minimum this role requires a Bachelor’s Degree in an Engineering Discipline (preferably Mechanical, Biomedical, or Aeronautical).
  2. 3 to 5 years of Design related experience is preferred but not required. Internship experience will be considered on a case by case basis.

Skills/Qualifications

  1. Communication Skills, specifically the ability to convey technical information effectively in both verbal and written medium
  2. Computer Skills

Computer Program

Required/ Preferred

MS Word

Required

MS Powerpoint

Required

MS Excel

Required

Minitab

Required

SolidWorks

Required

Creo/ Pro Engineer

Preferred

MathCAD

Preferred

Marc/ Mentat or Similar CAE Software

Preferred

 

  1. Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is required.
  2. Has a proven track record of experience in designing disposable multi component mechanical systems with between 15-50 components
  3. Working knowledge of Engineering Statistics is required.
  4. Skill in engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
  5. Advanced understanding of Plastics and Metals including processes for manufacturing these components for the healthcare industry is required.
  6. Understanding of the fundamentals of Finite Element analysis is preferred.
  7. Understanding of methods of inspection is required.
  8. Ability to conceptualize and document creative mechanical solutions to challenging problems are required.
  9. Physical hand assembly common to the production environment is required for this position.
  10. Ability to use basic machine shop equipment is required for this position. Use of drill presses, grinding wheels, manual lathes, etc. is a must.
  11. Ability to perform testing, collect data, and analyze data is required.
  12. Expert level knowledge of 21 CFR 820/ ISO13485 Design Controls
  13. Proficient knowledge of Process development and Process Validation.
Nissha Medical Technologies is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, 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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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
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