manufacturing Engineer

Q1 Technologies, Inc

Aurora, IL

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JOB DETAILS

SKILLS

ABET (Accreditation Board for Engineering and Technology), Aeronautical Engineering, Aerospace Engineering, Analysis Skills, Bill of Materials (BOM), Bioengineering, Biomedical Engineering, Calendar Management, Capacity Requirements Planning (CRP), Capital Equipment, Casting, Change Control, Change Management, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cost Analysis, Cost Estimates, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Document Management, Documentation, Engineering Drawing, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Feasibility Analysis, ISO (International Organization for Standardization), Identify Issues, Leadership, Machining, Maintain Compliance, Manufacturing, Manufacturing Engineering, Mechanical Engineering, Medical Equipment, Microsoft Office, Molding Processes, Network Routers, Options Analysis, Orthopedics, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Product Costing, Project Planning, Project Schedule, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality System Requirements (QSR), Regulations, Reporting Skills, Risk Analysis, Root Cause Analysis, Service Delivery, Statistical Process Control, Statistics, Technical Recruiting, Technical Support, Technical Writing, Time Management, Trend Analysis, Validation Testing, Writing Skills

LOCATION

Aurora, IL

POSTED

1 day ago

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:-

(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

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. 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

About the Company

Q1 Technologies, Inc

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.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Computer/IT Services

FOUNDED

1990

WEBSITE

http://q1tech.com/

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