Highlights
Education Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines, 2-4 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering. Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
Numbers & Facts
| Location | Aurora, IL |
| Industry | Computer/IT Services |
| Company Size | 500 to 999 employees |
| Year Founded | 1990 |
| Website | http://q1tech.com/ |
Description
Hi
Trust you are doing well.
I came across your information, and I wanted to see if you are interested in exploring opportunities. Please review the below job description and contact me ASAP.
***Please disregard this email if you feel you received it in error or are not looking for a new opportunity. Your resume has been identified in our database as a potential fit for an opening with one of our clients***
Job Title:- manufacturing Engineer
Job Location:- Warsaw, IN (Onsite)
Employment Type:-Contract
Job Description:-
Thanks & Regards,
Trust you are doing well.
I came across your information, and I wanted to see if you are interested in exploring opportunities. Please review the below job description and contact me ASAP.
***Please disregard this email if you feel you received it in error or are not looking for a new opportunity. Your resume has been identified in our database as a potential fit for an opening with one of our clients***
Job Title:- manufacturing Engineer
Job Location:- Warsaw, IN (Onsite)
Employment Type:-Contract
Job Description:-
- (Prior Client Biomet experience is preferred)
Technical/Functional Skills - Experience supporting medical device manufacturing
- Process Validations
- Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
- EOL validations including Cleaning, Upgrade and Packaging
- Specific experience with Test method Validation and Gage R&R
- Experience with root cause analysis and problem-solving for both technical and process issues
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner
- Good problem-solving skills using quality and statistical tools
- BOM & Router creation and update
- Ability to read and understand engineering drawings
- Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
- Knowledge of Quality System requirements, ISO and FDA requirements
- Ability to effectively work within a cross-functional team to complete critical project tasks
- Demonstrates good written and verbal communication skills
- Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts
- Microsoft Office Suite and Project
Experience Required 4 - 6 years
Roles & Responsibilities - Develops and Executes Process Validation Strategies for EOL including Cleaning and Packaging: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment.
- Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge.
- Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for process improvement.
- Collaborates Cross-Functionally: Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.
- Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
- Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
- Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
- Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements
- Establishing and improving process methods that meet performance and quality requirements
- Developing and executing project plans and schedules for work activities
- Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
- Evaluating multiple options to select the most appropriate processes and machining methods
- Execute equipment qualification or process validation project(s)
Generic Managerial Skills Not Mandatory
- Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines, 2-4 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering. Medical device, particularly the Orthopedic industry, experience preferred
Thanks & Regards,
| Manoj Kumar | Technical Recruiter Tel: +1 630 536 8202 Ext. 5581 | Direct: 630-937-0281 Manoj.Yadav@q1tech.com | www.q1tech.com |Address:- Aurora, Illinois, 60504 Over 23 Years of Innovation and Excellence in Delivery of IT Services USA | India | Canada | UK | UAE | Mexico |
About Company
Q1 consists of experienced and recognized experts providing the capability to respond to market demand in order to provide professional services for our clients including Enterprise software implementations, application integration and technical / functional support.
Q1 has steadily grown into a Quality IT services and solutions organization with the average experience of our team being over 10 years. We have continuously met or exceeded client expectations by delivering professional services and project implementations on time and under budget to help clients truly recognize return on investment.
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