Nissha Medical Technologies · 16 hours ago
Manufacturing Engineer II
Colorado, United States
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
3+ years expNissha Medical Technologies is looking for a Manufacturing Engineer II to join their Colorado Springs Team. This role will provide engineering support to manufacturing operations, focusing on developing and improving manufacturing methods, systems, and processes to ensure high-quality product production at optimal costs.
Consumer GoodsManufacturingMedical Device
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
Demonstrates knowledge and acts in accordance of NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual
Abides by all safety and security rules set forth by the company and regulatory agencies
Regular attendance is required
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
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
Qualification
Required
A minimum of 3 years of experience in a manufacturing or productions environment
Bachelor's Degree in Engineering
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)
Experience writing protocols, reports and engineering change orders
Preferred
Advanced degree in Engineering
One year of medical device manufacturing or manufacturing in highly regulated environment
Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11
Experience designing and conducting DOEs using MiniTab
Benefits
Medical
Dental
Vision
401k
Short-Term Disability
Long-Term Disability
Basic and Voluntary Life Insurance
Paid Vacation Time
Paid Sick Leave
Educational Assistance
And more
Company
Nissha Medical Technologies
Nissha Medical Technologies manufactures and designs custom label products, electrodes and medical devices.
1001-5000 employees
H1B Sponsorship
Nissha Medical Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageLeadership Team
Michael Memminger
CFO
Recent News
2025-04-10
Buffalo Business First
2025-03-26
Buffalo Business First
2025-03-01
Company data provided by crunchbase