Development Engineer III

This role is a technical engineering lead responsible for design, manufacturing development and transferring new products to Production. The Development Engineer III will direct and coordinate engineering activities for multiple development projects. The ideal candidate will know and apply the fundamental concepts, practices, and procedures of their field of specialization. Under limited supervision, this role will perform work that is varied and technically challenging, and take ownership of project deliverables and performance. Evaluation, originality, and ingenuity are required. The Development Engineer III typically reports to Engineering Management or a Project Team Leader and may supervise other Engineers and Technicians.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrates knowledge and acts in accordance with NMTs Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Designs products or systems such as surgical devices, mechanisms, fixtures, equipment, and injection molded components.
• Plans and directs personnel in fabrication of prototypes, first articles, test equipment, and development methods and procedures for manufacturing and testing products or systems.
• Facilitates reviews and executes test protocols and set-up of necessary methods to validate initial design and process selections.
• Creates project development plans, product specifications, conceptual designs and manufacturing concepts.
• Selects materials based on customer requirements and NMT's capabilities.
• Provides design, process and material related input related to products and manufacturing processes.
• Generates Test Reports, Drawings, Procedures, Routers, Specs, ECO's and other Technical Reports in accordance with Good Documentation Practices (GDP).
• Creates, reviews and updates Manufacturing Assembly Instructions.
• Validates manufacturing processes. Facilitates or performs process characterization and process validation on components/products according to NMT's procedures and / or customer requirements.
• Performs Test Method Validation (TMV) including Gauge R&R studies.
• Facilitates initial tooling trials. Troubleshoots tooling performance, process performance, design and material related issues during manufacturing start up.
• Facilitates or performs process characterization (DOE) on components/products according to NMT's procedures and/or customer requirements.
• Supports or provides quotation for potential new products, which include selection of correct materials, processes, tooling and equipment.
• Participates/leads various project teams and conference calls while representing NMT to the customer.
• Develops appropriate vendor contacts, approves prototype raw materials and assists in vendor certification.
• Trains, mentors other Engineers and Technicians.
• Abides by all safety and security rules set forth by the company and regulatory agencies
• Regular attendance is required.
• Other duties as assigned.

• Bachelor's Degree in Engineering
• Advanced Degree in Engineering (preferred)
• Minimum of 5 years of related experience in an engineering field. Lesser experience considered with advanced degree.
• Experience with CAD (SolidWorks preferred)
• Experience designing and conducting DOEs using MiniTab (preferred)
• Experience working in regulated environment. Medical device experience preferred.
• Successful experience in a technical leadership role (Preferred).
• Ability to plan activities, work independently and complete work on schedule.
• Skilled in writing protocols, reports and engineering change orders.
• Working knowledge of process validation (including IQ, OQ, PQ) strongly preferred.
• Proficient in CAD with experience in creating Engineering Drawings and applying GD&T (SolidWorks experience and proficiency preferred)
• Solid interpersonal and communication skills and the ability to work in a team environment.
• Strong problem-solving skills and efficient management of time and resources.
• Experience with plastic injection mold tooling and processing preferred.
• Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11 preferred.
• Experience designing and conducting DOEs using MiniTab preferred.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams)