Amanda B. Linen

**** ****** *** *** *** ● Raleigh, NC 27616 ● 919-***-****● acr2h0@r.postjobfree.com

SUMMARY:

Mechanical Engineer with fifteen years of experience in Project, Process and Quality Engineering.

Strong leadership, interpersonal, analytical, organizational, negotiation, motivational, written & oral communication skills

KEY SKILLS:

Software & Hardware Quality Assurance

Leadership

Project Management

Process Improvement

Budget Managing

Staff Development and Training

Customer Support/Customer Relations

Data Collection and Analysis

Meeting Facilitation

Team Player

Process Audits

Conflict Resolution

Quality Assurance Testing

Status Preparation and Presentation

Microsoft Office Suite of Products

TECHNICAL SKILLS:

Software Knowledge: Word, Excel, Access, Outlook, Power Point, Project Professional, Minitab, LabVIEW

Programming Knowledge: PLC and HMI Programming

PROFESSIONAL EXPERIENCE:

Quality Assurance Engineer/Team Leader – Robling Medical formerly Apogee Medical, Youngsville, NC 06/01/2009 – Present

Serve as a Lead Engineer on a team of seven

Organize and delegate the team’s workload

Monitor assignments to ensure they are completed correctly

Report status of monthly builds to management

Assist Maintenance/Manufacturing as needed on automated equipment troubleshooting

Primary contact with customer to communicate and implement design changes

Apply customer and company standards and procedures in all the work that is performed

Interpret customer specifications and flow requirements into internal process documents to ensure compliance with customer requirements

Assist in providing technical advice on preparing and editing technical scope documents.

Perform testing of electromechanical DAQ system to verify build is in compliance with customer requirements

Assist Customer in ensuring electromechanical device is UL compliant

Introduce new processes from validation to full scale production

Develop and Execute Engineering Studies, Operational/Process Qualification Protocols; Develop Engineering Study/Operational/Process Qualification Reports

Develop Operation Instructions, Assembly Instructions, Flow Tags, In-Process Inspection Forms, TRQ

Develop Component Specifications for medical devices and electromechanical hardware

Develop Bills of Material for electromechanical assemblies and disposable medical devices

Draft, review and approve ECN spec changes

Assist other engineers in the development and preparation of project proposals

Assist in communicating and training all Quality Department Team Members, Team Leaders, and team members on initiated process changes

Perform Internal Audits of Quality Systems; ISO 13485 Certified Internal Auditor

Perform Supplier Audits

Write Audit Reports, document findings and corrective actions

Implement corrective action plans to improve products and processes

Facilitated successful ISO 13485 Certification renewal

Used Failure Mode Effects Analysis (FMEA) to determine risks of new processes and equipment

Create and update process flow diagrams

Lead team of operators to conduct Gage R&R study on various tooling

Perform Root Cause Analysis and write Customer Complaint Reports

Write non-conforming material reports and temporary deviations

Receiving Inspection (Visual and Functional Testing) of components and electromechanical hardware according to component specifications/drawings

Improved receiving inspection process by defining critical dimensions and implementing functional testing

Process Engineer – Covidien formerly Tyco Healthcare, Raleigh, NC, 09/2004 – 10/31/2008

Project leader on teams of Contractors and Maintenance Personnel with equipment installations and rebuild

Technical lead on R&D team to develop new product labels for upgraded process; Lead bi-weekly teleconferences with local and corporate personnel

Obtained multiple quotes and service cost estimates for establishing budgets for capital projects

Presented justification for capital requests to upper management with budgets of $400k+

Coordinated multiple capital projects as Project Lead to ensure on-time, within budget completion; responsibility encompassed team and contractor oversight, project development, research, documentation, scheduling and implementation

Develop User Requirements Specifications and Engineering Studies

Led meetings to review requirements with affected Department Leads

Assisted Validation with the development and execution of Installation/Operational/Process Qualification Protocols

Reviewed and Updated Control Drawings for project execution

Led equipment downtime tracking efforts, utilizing information to predict equipment failures to reduced downtime by 30%

Created and updated Preventive Maintenance Schedules based on downtime data

Work multiple shifts and weekends to complete/execute projects and support production

Team member – EHS Management System: Assisted in the creation of a comprehensive EHS SOP for Contractors, Vendors and Temporary Employees

Senior Project Engineer – Baxter Healthcare, Marion, NC, 05/1998 - 09/2004

Project Leader with budgets of $100k+; Generated savings up to $300k/year

Led teams of Maintenance and Contractor Personnel with Machine Upgrades and Installations

Responsible for obtaining quotes and service cost estimates for capital projects

Called upon to work multiple shifts to maintain production

Implemented Preventive Maintenance Schedules

Utilized fundamentals of Six Sigma to Troubleshoot Manufacturing Equipment

Developed strong interpersonal, communication and team oriented skills

Recognized for Environmental, Health and Safety contributions

EDUCATION:

UNIVERSITY OF SOUTH CAROLINA, Columbia, SC

Degree: Bachelor of Science in Mechanical Engineering

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