Nissha Medical Technologies is looking for a Manufacturing Engineer II to join our Team in Colorado Springs CO!
This position will provide engineering support to manufacturing operation on a routine basis. The successful candidate will develop and improve manufacturing methods systems and processes to produce a high-quality product at optimal cost. Acting under general supervision the manufacturing Engineer II will be responsiblefor completing multiple assignments of moderate scope and complexity.
ESSENTIAL FUNCTIONS AND BASIC DUTIES (other duties may be assigned)
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 or regulations are met.
- Demonstrates knowledge and acts in accordance of NMTs Employee Guidelines and applicable quality standards as outlined in NMTs Quality Manual.
- Abideby all safety and security rules set forth by the company and regulatory agencies
- Regular attendance is required.
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.
- Ensures compliance with GMPs and internal protocol.
- Uses 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.
REQUIREMENTS:- Bachelors Degree in Engineering
- A minimum of 3 years of experience in a manufacturing or productions 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 (IQOQ PQ)
- 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
The established Compensation Range for this position will be $70000 to $80000 per year(paid on a bi-weekly basis) 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 EducationalAssistance and more!NisshaMedical Technologies is an Equal Opportunity Employer and considersapplicants 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 addition NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process please call .
Nissha Medical Technologies is looking for a Manufacturing Engineer II to join our Team in Colorado Springs CO!This position will provide engineering support to manufacturing operation on a routine basis. The successful candidate will develop and improve manufacturing methods systems and processes t...
Nissha Medical Technologies is looking for a Manufacturing Engineer II to join our Team in Colorado Springs CO!
This position will provide engineering support to manufacturing operation on a routine basis. The successful candidate will develop and improve manufacturing methods systems and processes to produce a high-quality product at optimal cost. Acting under general supervision the manufacturing Engineer II will be responsiblefor completing multiple assignments of moderate scope and complexity.
ESSENTIAL FUNCTIONS AND BASIC DUTIES (other duties may be assigned)
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 or regulations are met.
- Demonstrates knowledge and acts in accordance of NMTs Employee Guidelines and applicable quality standards as outlined in NMTs Quality Manual.
- Abideby all safety and security rules set forth by the company and regulatory agencies
- Regular attendance is required.
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.
- Ensures compliance with GMPs and internal protocol.
- Uses 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.
REQUIREMENTS:- Bachelors Degree in Engineering
- A minimum of 3 years of experience in a manufacturing or productions 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 (IQOQ PQ)
- 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
The established Compensation Range for this position will be $70000 to $80000 per year(paid on a bi-weekly basis) 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 EducationalAssistance and more!NisshaMedical Technologies is an Equal Opportunity Employer and considersapplicants 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 addition NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process please call .
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