DIPKUMAR PATEL
Edison,NJ
Summary
Seasoned Process Engineer with experience in medical device manufacturing and process development/improvement with a focus on continuous improvement.
Overview
5
5
years of professional experience
Work History
Production Engineer
Getinge
Wayne , NJ
2019.09 - 2021.12
- Formulated and executed process validation protocols including IQ/OQ/PQ and Test method validation.
- Created and improved Standard Operating Procedures and work instructions for production of medical devices.
- Presented process change/update proposals in inner-departmental meetings for review and approval.
- Routed various change notices to update manufacturing processes and Engineering Protocols.
- Updated and maintained Engineering documents utilizing Trackwise and Windchil.
- Collaborated on Remediation CAPA Implementation Action Items such as updating procedures, adding inspection step or tolerance, collecting evidence of successful completion of various action items.
- Volunteered and served as resource to various cross-function department projects.
Process Engineer
Nobel Biocare
Mahwah , NJ
2016.12 - 2019.04
- Operated CNC machines such as Mikron, Willemin Macodel, Roeders to mill test samples needed for process optimization experiments and new development.
- Operated Zeiss (coordinate measurement machine) to measure product features on new development batches of dental restorations such as abutments, and bridges.
- Wrote protocols, qualification documents, test plans and test reports for quality assurance purposes.
- Conducted PFMEA, DOE, GR&R and SPC analysis for various manufacturing processes.
- Collaborated successfully with cross-functional teams such as CAM development, IT infrastructure, Quality Assurance to ensure all aspects of process are sustainable.
- Continually improved methods and procedures for processes to reduce waste, and sustain first pass yield of 95% and above.
- Managed engineering changes using SAP systems.
- Participated in Kaizen events for continues process improvements such as Standard Work, VRK, Poke yoke.
- Created SOP's and trained operators to maintain standard procedures in manufacturing.
- Participated in PSPs to identify root causes in manufacturing process using six sigma tools and provided sustainable solutions.
Material Technician
Nobel Biocare
Mahwah , NJ
2016.06 - 2016.12
- Tested various dental ceramics for their mechanical and optical properties as per ISO 6872.
- Carried out statistical analysis on data generated using Minitab to make technical decisions.
- Benchmarked various dental zirconia materials to support product development.
- Complied with EHS requirements such as maintaining SDS checklist of materials present in lab, and availability of PPE.
Education
Bachelor of Science - Biomedical Engineering
Rutgers, The State University of New Jersey
New Brunswick, NJ2015
Skills
- CNC machining, 3D printing, ISO standards, cGMP, Stastistical analysis, Validation/Verification, kaizen/Six Sigma tools, Complex problem solving, Team leadership, Strong communication skills, Project management.
- Programs: Minitab, Matlab, Solidworks, Microsoft Word, PowerPoint, Excel.
Projects
Infrascope Stethoscope, 09/2014 to 05/2015
- Designed and developed an Infrascope Device to detect early stages of CAD (carotid artery disease) by elevating the low frequency sound waves of bruit noise coming from little turbulent blood flow.
- Tested different circuits to amplify and shift sub-audible sound waves indicative of the disease.
- Performed experimental tests on full rectifier circuit using Biopac to gain optimal frequency range.
- Conceptualized the design of the medical device using solidworks.
Timeline
Production Engineer
Getinge
2019.09 - 2021.12
Process Engineer
Nobel Biocare
2016.12 - 2019.04
Material Technician
Nobel Biocare
2016.06 - 2016.12
Bachelor of Science - Biomedical Engineering
Rutgers, The State University of New Jersey
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