Job Description
Manufacturing Engineer II at Nissha Medical Technologies Manufacturing Engineer II at Nissha Medical Technologies in Colorado Springs, Colorado Posted in 4 days ago. $70,000.00 - $85,000.00 per year
Job Description:
JOB DESCRIPTION
Manufacturing Engineer II About Nissha Medical Technologies Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE:
7915). Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients' lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement. At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you're motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you'll find a place to belong at NMT. What You Will Do The Manufacturing Engineer II will provide 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 Manufacturing Engineer II acts under general supervision of the Manufacturing Engineering Supervisor on multiple assignments of moderate scope and complexity. General 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 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. Other duties may be assigned. Production Support and Troubleshooting:
Provide engineering support to manufacturing operation 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. Customer Support:
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. Continuous Improvement and Cost Reduction:
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. Concurrent Engineering:
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. Ensure compliance with GMP's and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations. Equipment and Fixturing:
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. Qualification and Validation:
Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies. Documentation:
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. What You Bring Core Qualifications Bachelor's Degree in Engineering A minimum of 3 years of experience in a manufacturing or production environment Solid interpersonal and communication skills and ability to work in a team environment 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) Preferred Qualifications Experience writing protocols, reports and engineering change orders Advanced degree in Engineering preferred One year 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 Experience designing and conducting DOEs using MiniTab preferred Professional Traits We Value Problem-solving ability Hands-on Mentality Strong Project Management skills Continuous Improvement Mindset Team-player Compensation & Benefits The expected salary range for this position is $70,000 - $85,000 annually. Actual compensation will be determined based on experience, skills, qualifications, and geographic location. In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities. Equal Opportunity Statement Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.
