Principal Design Engineer

Nissha Medical Technologies is looking for a Principal Design Engineer to join our Team in Wolcott, CT!

This position will provide leadership through example and will deliver technical outputs in the design and development of Medical Device product solutions. These product solutions may be systems that are mechanically or electromechanically based. The design process utilized shall follow Quality System and standard operating procedures of Nissha Medical Technologies/Sequel.

The ideal Candidate will demonstrate a track record of successfully executing and completing design projects from start to finish. This individual has established a reputation both internally and externally for delivering 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 other employees to positively impact the quality and brand of the organization. This individual consistently demonstrates a willingness to ensure 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 person also works synchronously with project managers and the design division management.

ESSENTIAL FUNCTIONS AND BASIC DUTIES (other duties may be assigned)

• 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.
• Regarded as a technical leader that provides mentorship to other engineers.
• Demonstrates the ability to communicate technical information to the customer through routine reporting and project status reviews.
• Works with engineering management to provide support for Design and Development process improvements that will enable divisional growth through scalability.
• Supports and leads product design and development projects using a solid understanding of principles related to Human Factors and Usability
• Provides support for maintaining and managing the Design Control system in compliance with 21 CFR 820 and MDSAP ISO 13485.
• Develops product specifications derived from customer requirements.
• Conceptualizes 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.
• Performs engineering analysis as a means of verifying that product concepts have engineering merit and have a high likelihood of meeting the product specifications.
• Performs detailed design of product solutions including CAD Modeling, Design for Manufacturability and Assembly, Material selection, and Drawing Specifications.
• Develops detailed drawing of components and assemblies identifying critical criteria to ensure product quality.
• Identifies suppliers of components and procure prototype component samples.
• Performs initial engineering builds of design prototypes.
• Performs prototype evaluations and debug samples as required.
• Develops test methods and procedures for verifying that a design meets the product specifications.
• Prepares protocols and reports of various types included as part of design verification.
• Develops procedures and instructions for assembling product designs.
• Specifies or modifies production processing equipment required for manufacturing the product.
• Researches and develops custom manufacturing processes as required.
• Designs, fabricates, and verifies the installation of assembly fixturing and manufacturing aids.
• Identifies, documents, and verifies critical in-process and final acceptance product quality criteria.
• Verifies and validates production equipment, processes, and test methods.
• Leads the risk management process required by the medical device industry.
• Supports, guides, and trains 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.
• Develops Master Validation plans including IQ, OQ, PQ, PPQ, and Gage R&Rs. Able to execute process validations as a technical lead.
• Abides by all safety and security rules set forth by the company and regulatory agencies.
• Regular attendance.
• Performs other duties as assigned.

• BS in an Engineering Discipline (preferably Mechanical, Biomedical, or Aeronautical). Masters preferred.
• 5-10 years of relatable Engineering experience is required.
• 3 to 5 years of Design related experience is preferred. Relevant Internship experience may be considered if applicable.
• Required Computer Skills include MS Word, MS Powerpoint, MS Excel, Minitab, SolidWorks. Crea/Pro Engineer, MathCAD and Marc/Menata or similar CAE Software are preferred.
• Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is required.
• Has a proven track record of experience in designing disposable multicomponent mechanical systems with between 15-50 components.
• A working knowledge of Engineering Statistics is required.
• Skill in engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
• Advanced 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 methods of inspection is required.
• Expert level knowledge of 21 CFR 820/ ISO13485 Design Controls
• Proficient knowledge of Process development and Process Validation.

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