Process Validation Engineer Resume Elkton, MD - Hire IT People

SUMMARY

Mechanical engineer wif 5 years of design, manufacturing and process development experience
DRM/DFSS Green Belt certified
Knowledgeable in medical device quality systems and product development lifecycle, offering expertise in process validation and manufacturing implementation
Strong background in characterizing manufacturing processes to robust standards by understanding first principals, applying predictive engineering, and employing statistical methods
Process development experience in adhesive bonding, thermal bonding, tube annealing, thermal shaping, laser cutting, laser marking, crimping, swaging, and soft tissue marking and sewing

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Process Validation Engineer

Confidential, Elkton, MD

Responsibilities:

Conduct process revalidation activities such as IQ, OQ, PQ on a remediation project for introducer sheaths
Led front end process development and manufacturing improvement projects for a bioprosthetic mitral valve
Designed fixtures, developed test methods, and conducted engineering studies for design verification of the valve and its loading and delivery systems
Remediated critical test reports in preparation for an IDE submission to the FDA

Manufacturing Process Engineer

Confidential, Mounds View, MN

Responsibilities:

Collaborated wif global teams on design, development and manufacturing transfer of next-generation medical device products including implantable leads for Cardiac Resynchronization Therapy (CRT), and ablation catheters and delivery systems for Atrial Fibrillation (AF)
Characterized manufacturing processes and validated test methods using statistical techniques like Design of Experiments (DOE), Response Surface Modeling (RSM), Monte Carlo Simulations and Gage R&R
Led process validation activities, and established process monitoring and control requirements
Worked wif vendors on development and qualification of custom-made equipment, tools and fixtures
Evaluated capability of sourced components, and drove improvements in supplier performance
Drove process and quality improvement projects using Lean principals and Six Sigma DMAIC methodology
Performed root cause analysis and developed corrective and preventative actions for production issues
Created and maintained risk assessment documents such as DFMEA and PFMEA
Worked wif a cross-functional team to iteratively improve the design and manufacturing processes of a pacemaker delivery and retrieval catheter system
Developed manufacturing processes, designed fixtures, and transferred them to a new cleanroom
Used Minitab to conduct DOEs and capability studies to understand process feasibility and capability
Designed and executed protocols, and generated reports for IQs and TMVs

Mechanical Engineering Intern

Confidential, Eagan, MN

Responsibilities:

Developed a design, using SolidWorks, to expand a cutting-edge dispensing technology to a new product line
Built prototypes and testing fixtures, and carried out DOEs to test the feasibility of design
Performed component testing and material selection for a thermal actuator design for chemical dispensing systems
Conducted tests in the R&D lab to assist wif new product development, and provided technical assistance to production
Built prototype wire harnesses for a new line of air conditioners, and prepared prototype build reports for several projects
Created wiring instructions and work instructions for a series of air conditioners, and assisted wif creating user manuals