Medical Device Process Validation Engineer
Resume:
CHAD R. GLIDDEN
**** *. ******** ***., **********, CO 80122 720-***-**** ***********@*****.*** OBJECTIVE
To utilize my technical education and experience and strong interpersonal skills in a challenging and growth-oriented position. PROFESSIONAL EXPERIENCE
Design Quality Engineer, Biodesix, Louisville, CO Oct 2024–Feb 2025
Applied Design Controls to Design History File (DHF) updates.
Generated and maintained risk documentation, including, but not limited to, Hazard Assessments, Risk Assessments, and Risk Reports.
Assisted in the development of statistically rationalized components and product acceptance inspection plans.
Evaluated design plans to comply with industry standards and regulations.
Maintained/developed quality records and designs of product DHFs.
Assisted in the development of Quality Management System (QMS) processes.
Performed data analysis, and developed, monitored, and oversaw metrics reporting.
Lead and supported continuous improvement activities.
Supported and participated in internal and external audits and inspections.
Generated/maintained procedures, work instructions, inspection plans, forms, and templates.
Lead Corrective Action and Preventive Action (CAPA) investigation.
Reviewed/approved verification & validation protocols and reports. Quality/Validation/Process Dev Engineer, TerumoBCT, Lakewood/Littleton, CO Jan 2018–Nov 2023
Plasma Collection Disposables, Process Validation Engineer o Designed, coordinated, executed, and analyzed validation activities (remote and in-person) at TerumoBCT (Littleton) facility (IQ, OQ, PQ, and TMV) o Collaborated with Process Engineers in Littleton o Developed validation activities for Supplier Manufacturers (New Jersey)
Vietnam Capacity Expansion (VCE), Process Validation Engineer o Designed, coordinated, and executed validation activities (remote and in-person) at TerumoBCT (Vietnam) facility (IQ, OQ, PQ, TMV)
o Collaborated with Process Engineers in Lakewood and Vietnam
Freeze Dried Plasma (FDP), Process Development Engineer o Plan, execute, and analyze verification activities (IQ, OQ, PQ, and TMV) o Collaborate with I&D, Quality, Process and Validation Engineers o Design manufacturing processes and procedures for new product development
New Product Development – Plasma Bottle, Process Validation Engineer o Designed, coordinated, and executed validation activities (remote and in-person) at Supplier facility (IQ, OQ, PQ, and TMV)
o Collaborated with Suppliers Engineers/Management and Supplier Quality and Process Engineers
Non-DEHP Validation, Process Validation Engineer o Designed, coordinated, and executed validation activities – Lakewood facility (IQ, OQ, PQ, and TMV)
o Collaborated with Process Engineers
Participated in evaluations of validated state of equipment at Lakewood facility
Participated in implementation of new document control system updates Quality/Validation/Manufacturing Engineer – Spectranetics, Colorado Springs, CO Sep 2016–Dec 2017
Provide support for Sustaining Manufacturing Engineers.
Work with Class II&III medical devices (Atherectomy Laser Catheters).
Design and implement solutions for continued improvement of manufacturing processes.
Ensure alignment with Manufacturing strategies and practices by working with multidiscipline groups to find sustainable solutions.
Collect data and performed statistical analyses on manufacturing processes to determine quality.
Create solid models and drawings of manufacturing fixtures and equipment.
Document and update manufacturing procedures to FDA standards.
Write, set up, and perform validation and verification testing of new fixtures and equipment.
Assist with investigation and implementation of corrective and preventive action (CAPA) plans.
Experience working with Change Management system.
Write and submit Engineering Change Orders (ECOs).
GMP.
Page 2 of 2
Design Control Engineer, Contract – Medical Device – Baxter, Englewood, CO May 2015–May 2016
Worked with Class II medical devices (syringes and accessories).
Updated medical device Design Master Records (DMR) documentation from legacy products into Baxter’s current quality system.
Worked with Quality and Regulatory personnel to create and update FDA quality control documentation for DMR.
Assisted with identifying corrective and preventive action (CAPA) plans
Helped identify improvement opportunities in the current product/process design activities and the final production process as well as create solutions to achieve those improvements or accomplishments.
Wrote and submitted Engineering Change Orders (ECOs). Design Control Engineer, Contract – Medical Device – TerumoBCT, Lakewood, CO Aug 2014–May 2015
Transferred Class II medical device (blood separating devices) Design History Files (DHF) documentation from acquired company into TerumoBCT’s quality system.
Developed, executed and analyzed various validation protocols and reports.
Worked with cross-functional personnel to create and update FDA quality control documentation for DHF.
Development and analysis of risk management documentation and DFMEAs.
Wrote and submitted Engineering Change Orders (ECOs). Manufacturing Engineer, Intern – Medical Device – ConMed Corp., Centennial, CO May 2013–Aug 2014
Worked with Class I&II medical devices (disposable electro-surgical device).
Ensured alignment with Manufacturing strategies and practices.
Collected data and performed statistical analyses on manufactured products to determine quality.
Created solid models and drawings of manufacturing fixtures and equipment.
Organized and facilitated qualification and validation (IQ, OQ, PQ) activities for multiple product lines.
Wrote, set up, and helped perform validation and verification testing of new fixtures and equipment.
Assisted with investigation and implementation of corrective and preventive action (CAPA) plans.
Assisted with the development and analysis of risk management documentation and PFMEAs.
Assisted with the development, manufacture and integration of new fixtures.
Performed Kaizen activities to help ensure flexibility in tooling and processes to support rapid integration of design changes and lean manufacturing.
Wrote and submitted Engineering Change Orders (ECOs). Secondary Science Teacher – Colorado 2000–2010
EDUCATION
Bachelor of Science in Mechanical Engineering Dec 2013 University of Colorado Denver – Denver, CO
Master of Science in School Counseling Dec 2005
University of Phoenix – Westminster, CO
Bachelor of Science in Biology; Bachelor of Science in Zoology May 1998 Secondary Teacher Certification Dec 2000
Colorado State University – Fort Collins, CO
TECHNICAL SKILLS
Six Sigma – Green Belt
Design and project experience using SolidWorks, Pro-E, MATLAB, MathCad, Abaqus, and LabVIEW
Data Analysis using Minitab (Gage R&R, SPC, Capability Analysis, Root Cause Analysis, Sample Size Determination
(IQ, OQ, PQ, and TMV with Variable/Attribute data)
Very strong Microsoft office skills in Excel and Word
Collaborative, Excels in cross-departmental communication and efficiency
Strong academic training in mechanical engineering, course work in a variety of engineering disciplines, and well- developed computer and CAD abilities
Hard working, dedicated, able to multi-task, outstanding communication skills
Contact this candidate