Manufacturing Engineer M&A Operations Integration
Apply NowCompany: Tata Consultancy Services
Location: Warsaw, IN 46580
Description:
Must Have Technical/Functional Skills
Experience supporting medical device manufacturing
Cleaning & Upgrade Validations
Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
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 ISO13485-2003
Ability 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, process development, CNC programming terminology, and tooling design concepts
Microsoft Office Suite and Project
Roles & Responsibilities
Supporting medical device manufacturing
Process characterization, equipment IQ/OQ, process OQ, and PQ
Test method Validation, Gage R&R
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
E xecute equipment qualification or process validation
Salary Range: $75,000-$120,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
Experience supporting medical device manufacturing
Cleaning & Upgrade Validations
Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
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 ISO13485-2003
Ability 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, process development, CNC programming terminology, and tooling design concepts
Microsoft Office Suite and Project
Roles & Responsibilities
Supporting medical device manufacturing
Process characterization, equipment IQ/OQ, process OQ, and PQ
Test method Validation, Gage R&R
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
E xecute equipment qualification or process validation
Salary Range: $75,000-$120,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1