Manufacturing Engineer III

Nissha•Colorado Springs, CO

About The Position

The Manufacturing Engineer III is a technical engineering lead responsible for providing engineering support to manufacturing operations on a routine basis. This position will develop and improve manufacturing methods, systems and processes to produce a high-quality product at optimal cost. The successful candidate will act under general supervision of the Director of Operations on multiple assignments of moderate scope and complexity, directs and coordinate engineering activities for multiple manufacturing projects and provide support for new product development projects. The ME III may supervise other Engineers and Technicians.

Requirements

Bachelor’s degree in engineering
A minimum of 5 years of engineering experience in a manufacturing or production environment. Or a minimum of 3 years with an advanced Engineering degree.
Experience with CAPA’s, MRB’s, and/or NCMR’s
Experience with statistical analysis of Production processes
Current or recent experience with equipment and/or process qualifications and validations (IQ,OQ, PQ)
Experience writing protocols, reports and engineering change orders

Nice To Haves

Experience designing and conducting DOEs using MiniTab preferred
Advanced degree in Engineering preferred
Three years of medical device manufacturing or manufacturing in highly regulated environment preferred
Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11 preferred

Responsibilities

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.
Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
Abide by all safety and security rules set forth by the company and regulatory agencies
Regular attendance is required.
May manage day to day activities of Manufacturing Engineering Team members (engineers or technicians).
May monitor Manufacturing Engineering productivity to ensure timely completion of tasks.
Provide guidance and coaching to other team members.
Set goals for performance in deadlines to align with company plan and vision.
Direct and coordinate Manufacturing Engineering team projects.
Provide engineering support to manufacturing operations on routine basis.
Address product related issues arising on the production floor.
Investigate non-conforming materials and products from receiving inspection and the production floor.
Initiate and own CAPAs as necessary.
Support supplier quality issues and changes in conjunction with the buyer.
Provide the customer with a dedicated SME for their product line.
Implement changes required by the customer and request changes to their production lines as needed.
Investigate customer complaints with Quality when necessary.
Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs.
Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
Perform cost analyses to reduce or optimize product costs.
Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
Ensures compliance with GMP’s and internal protocol.
Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters.
Collaborate on design with suppliers to fulfill equipment and fixturing requirements.
Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.
Define and generate all required documentation in support of manufacturing products and processes. These include: ECOs, Engineering protocols, FMEAs, reports, manufacturing instructions and procedures.
Maintain a high level of documentation that is clear and understandable, contains pertinent and accurate information, and will promote confidence with customers and auditors.