Nissha Medical Technologies
Manufacturing Engineer II
Nissha Medical Technologies, Colorado Springs, Colorado, United States, 80509
Nissha Medical Technologies is looking for a Manufacturing Engineer II to join our team in Colorado Springs, CO.
The successful candidate will develop and improve manufacturing methods, systems, and processes to produce a high‑quality product at optimal cost, providing engineering support to the manufacturing operation on a routine basis.
Pay Base pay range: $70,000.00/yr – $80,000.00/yr
ESSENTIAL FUNCTIONS AND BASIC DUTIES
General:
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.
Maintain regular attendance.
Production Support and Troubleshooting:
Provide engineering support to manufacturing operation on a 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 designs facilitate ease of manufacturing and produce quality, cost‑effective products with optimized yields.
Ensure compliance with GMP’s and internal protocols.
Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
Equipment and Fixturing:
Determine specific equipment, fixturing, and process parameter requirements.
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 using appropriate statistical methodologies.
Documentation:
Define and generate required documentation, including ECOs, Engineering protocols, FMEAs, reports, manufacturing instructions, and procedures.
Maintain clear and accurate documentation that promotes confidence with customers and auditors.
REQUIREMENTS
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 CAPAs, MRBs, and/or NCMRs
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
Advanced degree in Engineering preferred
One year of medical device manufacturing or manufacturing in a 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
Compensation & Benefits The established compensation range for this position will be $70,000 to $80,000 per year (paid bi‑weekly) based on experience and qualifications.
Great benefits available including 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!
Equal Opportunity Employer Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status.
In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
Application Instructions If you need assistance with completing the online application process, please call (719) 426‑9074.
Alternatively, you can apply to this job using your profile from Indeed by clicking the button below.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering and Information Technology
Industry Medical Equipment Manufacturing
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The successful candidate will develop and improve manufacturing methods, systems, and processes to produce a high‑quality product at optimal cost, providing engineering support to the manufacturing operation on a routine basis.
Pay Base pay range: $70,000.00/yr – $80,000.00/yr
ESSENTIAL FUNCTIONS AND BASIC DUTIES
General:
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.
Maintain regular attendance.
Production Support and Troubleshooting:
Provide engineering support to manufacturing operation on a 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 designs facilitate ease of manufacturing and produce quality, cost‑effective products with optimized yields.
Ensure compliance with GMP’s and internal protocols.
Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
Equipment and Fixturing:
Determine specific equipment, fixturing, and process parameter requirements.
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 using appropriate statistical methodologies.
Documentation:
Define and generate required documentation, including ECOs, Engineering protocols, FMEAs, reports, manufacturing instructions, and procedures.
Maintain clear and accurate documentation that promotes confidence with customers and auditors.
REQUIREMENTS
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 CAPAs, MRBs, and/or NCMRs
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
Advanced degree in Engineering preferred
One year of medical device manufacturing or manufacturing in a 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
Compensation & Benefits The established compensation range for this position will be $70,000 to $80,000 per year (paid bi‑weekly) based on experience and qualifications.
Great benefits available including 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!
Equal Opportunity Employer Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status.
In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
Application Instructions If you need assistance with completing the online application process, please call (719) 426‑9074.
Alternatively, you can apply to this job using your profile from Indeed by clicking the button below.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering and Information Technology
Industry Medical Equipment Manufacturing
#J-18808-Ljbffr