Manufacturing Engineer II

CEA Medical Manufacturing • Denver, CO • 1h ago

JOB DESCRIPTION

Nissha Medical Technologies is looking for a Manufacturing Engineer II to join our Colorado Springs Team! This role will provide engineering support to manufacturing operation on routine basis. The successful candidate will develop and improve manufacturing methods, systems and processes to produce a high-quality product at optimal cost. Acts under general supervision of Director of Operations on 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 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.

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 GMP's 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.

MINIMUM QUALIFICATIONS

Qualifications & Experience

A minimum of 3 years of experience in a manufacturing or productions environment

Education

Bachelor's Degree in Engineering

Knowledge, Skills, & Abilities

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 qualificationsand 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 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

Physical Requirements

This position requires the physical ability to:

Frequently remain in a stationary position for long periods of time.

Regularly use hands and fingers to make small movements and handle small parts/tools.

Frequently reach with hands and arms.

Occasionally move between buildings and offices (campus environment).

Frequently operate a computer and other office equipment.

Constantly and successfully communicate with employees, managers, and members of the public, in person and on the phone, regarding sensitive matters.

Occasionally lift and move up to 20 pounds.

Perform repetitive tasks using wrists, hands and fingers.

Some overtime may be required depending on project timeline.

The established Compensation Range for this position will be $70,000 to $80,000 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, Educational Assistance, and more!

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.

If you need assistance with completing the online application process, please call (719) 426-9074.Please Apply at: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjkxOTIxLjg3NjBAbmlzc2hhbWVkaWNhbHRlY2hjb21wLmFwbGl0cmFrLmNvbQ{rel="noopener noreferrer" target="_blank"}

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