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Manufacturing Engineer Consultant
Colorado Springs, CO
Job Description
Manufacturing Engineer working as part of a team supporting the production of disposable medical devices, such as laser atherectomy catheters for peripheral and coronary procedures, support catheters, and lead removal tools. This position does both daily sustaining and project work to optimize production safety, quality and output.
In this role, you have the opportunity to:
design, optimize and develop improvements to processes and equipment to allow products to be manufactured with efficiency and quality while maintaining compliance to ISO and FDA requirements.
You are responsible for:
Our daily work that includes both sustaining and project work we strive to complete the types of projects that remove the need for sustaining work improving safety, quality, output and eliminating scrap.
The team is frequently called to develop solutions to safety or ergonomic concerns, which may involve analyzing work methods, developing fixtures or identifying new ways of doing a task.
Daily sustaining work includes troubleshooting and developing solutions for various chemical and mechanical issues, especially with respect to the following: epoxies - mixing/ curing/ drying/ wicking/ polishing; plastic tubing - fusing/ flaring/ forming/ injection molding; fiber optics drawing, coating, curing, winding, stuffing, polishing; equipment troubleshooting/repair simple mechanical machines, temperature controllers, PLC s, HMI s, motion controllers, etc.; packaging and sealing pouches and trays; cleaning ultrasonic, ionizers; testing burst, tensile, leak, optical gauge, FTIR, DSC, SEM; CAD modeling Solidworks, and more!
Process validation and verification work is frequently required knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a and a clear understanding of FDA s QSR and cGMP, and a good grounding in statistics would be instrumental to success.
The Manufacturing Engineer will be expected to organize investigations, pursue a logical course of inquiry, be able to collect and analyze data and see patterns/trends, analyze the results to fully understand root cause and implement solutions that will prevent reoccurrence.
We highly value engineers who are able to use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, safety while lowering costs.
Contributing to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. Training less experienced personnel on established methods and procedures. Facilitating the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.
Communicating fully with management and others who have a need to know. Being informative and communicating in a way that is timely, concise, clear and accurate.
The manufacturing engineering team on the front line of daily production issues for established product lines. Also be the manufacturing engineering teams' link working with the maintenance team to ensure IQ's, OQ's and changes they need to support keeping production running.
To succeed in this role, you ll need a customer-first attitude and the following.
BS in Mech Eng, or similar discipline preferred
2-3 Years of Solidworks experience as a daily user.
Process validation and exposure the regulated environments and associated requirements
Lean Manufacturing experience highly desired. Standard work and Line Balancing within Lean Manufacturing is a must
In this role, you have the opportunity to:
design, optimize and develop improvements to processes and equipment to allow products to be manufactured with efficiency and quality while maintaining compliance to ISO and FDA requirements.
You are responsible for:
Our daily work that includes both sustaining and project work we strive to complete the types of projects that remove the need for sustaining work improving safety, quality, output and eliminating scrap.
The team is frequently called to develop solutions to safety or ergonomic concerns, which may involve analyzing work methods, developing fixtures or identifying new ways of doing a task.
Daily sustaining work includes troubleshooting and developing solutions for various chemical and mechanical issues, especially with respect to the following: epoxies - mixing/ curing/ drying/ wicking/ polishing; plastic tubing - fusing/ flaring/ forming/ injection molding; fiber optics drawing, coating, curing, winding, stuffing, polishing; equipment troubleshooting/repair simple mechanical machines, temperature controllers, PLC s, HMI s, motion controllers, etc.; packaging and sealing pouches and trays; cleaning ultrasonic, ionizers; testing burst, tensile, leak, optical gauge, FTIR, DSC, SEM; CAD modeling Solidworks, and more!
Process validation and verification work is frequently required knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a and a clear understanding of FDA s QSR and cGMP, and a good grounding in statistics would be instrumental to success.
The Manufacturing Engineer will be expected to organize investigations, pursue a logical course of inquiry, be able to collect and analyze data and see patterns/trends, analyze the results to fully understand root cause and implement solutions that will prevent reoccurrence.
We highly value engineers who are able to use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, safety while lowering costs.
Contributing to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. Training less experienced personnel on established methods and procedures. Facilitating the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.
Communicating fully with management and others who have a need to know. Being informative and communicating in a way that is timely, concise, clear and accurate.
The manufacturing engineering team on the front line of daily production issues for established product lines. Also be the manufacturing engineering teams' link working with the maintenance team to ensure IQ's, OQ's and changes they need to support keeping production running.
To succeed in this role, you ll need a customer-first attitude and the following.
BS in Mech Eng, or similar discipline preferred
2-3 Years of Solidworks experience as a daily user.
Process validation and exposure the regulated environments and associated requirements
Lean Manufacturing experience highly desired. Standard work and Line Balancing within Lean Manufacturing is a must
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2 to 3 years
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