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Process Development Engineer Resume Samples
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0-5 years of experience
Senior SME for Process Development and Improvement adhering to CFR Part 211, GMPs and ICH Q7A FDA guidelines.
- Spearheaded an L&E FMEA study and carried the resulting replacement of gaskets, valves, and diaphragms for process equipment such as Reactors, Portable Tanks, Cuno Filter, Westfalia centrifuges, Millipore TFF Skid and chromatography Packed column.
- Wrote and Supervised the manufacturing of a Fractionation first batch for CMO client resulting in improving yield (15%) and reducing cycle time (16 hrs).
- Carried out a FMEA for Ethylene Glycol cooling usage resulting in improved cooling, less leakage and reduced cross contamination potential. Mitigate gap analysis and initiated remediation actions for Manufacturing.
- Reviewed internal IQ, OQ, PQ documentation against ASTM E2500 requirements. Assisted with validation execution and approval of documentation.
- Revised URS and FRS for Westfalia centrifuges. Review and approved P&IDs and automation control panels for equipment.
0-5 years of experience
- Designs, manufactures, and distributes printed electronics.
- Relate professional process engineering and manufacturing principles and practices whereas determining changes to variable processes
- Applied problem-solving skills for troubleshooting and rework for various types of printed electronics, for issue reported by manufacturing personnel, and customers. Reduce capacitance on circuit by reorganizing and re-dimensioning traces sizes
- Developed a process resulting in 40% manufacturing scrap reduction
- Evaluated data on manufacturing process leading to product yield and reliability enhancement, resulting in substantial burn-in reduction.
- Eagerly reduced cycle time by 35% and Streamlined departmental operations on a continuing basis through improved equipment reliability and operator development
- Provided on-going support for modification and de-bugging of manufacturing and material handler automation equipment, resulting in a major reduction in down time.
- Successfully lead a team of four production operator
0-5 years of experience
- Led a cross-functional team as part of a six sigma project to increase manufacturing yields from 71% to 98%. Annual cost savings of $1.7M.
- Six sigma project to optimize heatshrink recovery operation. Eliminated ergonomic and safety risks associated with the process and reduced cycle time by 40%. Annual cost savings of $12K.
- Supported new product development through engagement with the R&D group including leading process validation efforts for both balloon expandable stent and balloon catheter projects.
- Introduced new and modified existing equipment to eliminate bottlenecks on the manufacturing line. Increased manufacturing capacity by 40%, decreased lead time by 40% and decreased WIP inventory by 75%.
0-5 years of experience
- Reduced fired cracks in siliconized product through control of slip properties
- Developed innovative siliconization techniques to reduce under-impregnation defects to approximately zero
- Employed a combination of innovative siliconization practices that increased the lifetime of siliconization
6-10 years of experience
Designed and developed the chemical process to combine the Semprus Sustain(TM) antimicrobial surface with medical devices including vascular catheters, endotracheal tubes, and contact lenses.
- Took initiative to independently explore novel means of conducting surface chemistry that resulted in a 50% reduction in cycle time and 33% reduction in material costs.
- Designed reaction vessels and fluid flow systems to enable process improvements.
- Traveled to affiliate Teleflex divisions to communicate technology, design, and process strategy.
- Managed two co-ops while serving as process lead for new product lines.
0-5 years of experience
Porous Particle High Throughput Process
- Planned and executed development study protocols with a team of engineers and technicians that increased Porous Particle production by 100% on next generation Porous Particle spray dryers with newly discovered parameters.
- Established and recommended key process control measures for high throughput process to senior engineers by gap analysis of current and historic commercial manufacturing process data.
- Led three technicians in the expansion, qualification, and build of second generation spray dyers to triple production capability in response to company’s first FDA approved COPD product, BEVESPI AEROSPHEREâ„¢.
- Drafted various technical memos, SOPs, and trained engineers and technicians on operation, maintenance, and troubleshooting of new spray dryers and HMI’s.
0-5 years of experience
- Responsible for the upstream development, optimization, scale up and production of recombinant AAV vector gene therapies.
- Upstream subject matter expert (SME) for all pipeline projects. Supports Person-In-Plant (PIP) activities to ensure technical oversight of CMO manufacturing activities of all pipeline projects.
- Experience in training, managing and developing two direct reports. Evaluated employee performance and provided recommendations on future development.
- Lead efforts to introduce, evaluate and successfully implement scalable upstream technologies. Designed and executed studies to improve yield and batch consistency.
- Coordinated activities with downstream and internal Quality groups to ensure production timelines were met in order to supply drug product for pre-clinical and Tox studies.
- Independently managed upstream vendor relations by operating as a point of contact for the acquisition of consumables and capital equipment.
- Established an engineering track at [company name] by engaging HR and key stakeholders regarding the need for a new class of individual contributor roles.
0-5 years of experience
- Collaborated with a team of two yield engineers to implement process improvements for the weekly yield report.
- Built functions in Visual Basic designed to automate the yield report to decrease the yield update time from 2 to 1 hour weekly.
- Built and maintained, using data mining techniques, an extensive database gathering the majority of the process parameters of the 300,000+ sq ft manufacturing plant to facilitate the data analysis process.
- Investigated process defect occurrence by mining, extracting and reorganizing real-time data in order to perform extensive data analysis through Excel and Visual Basic.
- Reported behaviors of process parameters identifying relevant correlations on a bi-weekly basis to a team of process engineers, yield engineers and researchers.
- Worked with the Purchasing and Planning team to increase delivery rate and minimize overrun by developing a launch model accounting for several contributing factors.
- Partnered with process and manufacturing engineers to draft detailed work instructions for glass handling and storing, which were reviewed by quality managers and manufacturing personnel and implemented in August 2016.
0-5 years of experience
- Supported manufacturing line transfer and validation for Percutaneous Heart Pump (PHP) to Minnesota
- Wrote specifications/protocols and coordinated with design group to develop and IQ process equipment
- Analyzed and improved test methods through screening experiments and released TMVs & Gage R&Rs
- Analyzed/investigated legacy data to identify sources and improved variation in impeller alignment
- Authored and revised work instructions, test methods, inspection methods and tech reports as part of OQ
- Revised OQ/PQ reports as part of a remediation project to bring them up to company standards and QSR
- Characterized viscosity and derived new method reducing time from 5 minutes to 10 seconds
6-10 years of experience
Key development engineer of high volume manufacturing and complex device fabrication flows for passive and active microelectromechanical systems (MEMS) devices. Customer CEO award for excellence received for the work listed.
- Solved key project road blocks such as cracking, peeling, delamination, planarization, residues, process drift using design of experiment and statistical analysis techniques and well as other trouble shooting methodologies such as process segmentation. Characterization and failure analysis techniques such as SEM, ellipsometry, opto-acoustic pulsing, 4pt probe, FTIR, EDX, SEM, profilometry and optical microscopy were utilized.
- Process development of electrical and structural high volume manufacturing device modules using metals such as Titanium, Aluminum, Tungsten, Titanium Nitride, metal alloys such as Titanium Aluminum Nitride and Aluminum Copper.
- Enabled new on site capabilities such as wet only resist/ polymeric and residue cleans, low stress metal sputter deposition process, low stress chemical vapor deposition process, spin on polymer planarization techniques, surface enhancement for improved adhesion, surface passivation for improved structural stability during microfabrication. Also improved metrology capabilities using first-hand knowledge of inline metal thickness measurement and process control.
- Contributed to design improvements by devising test structures for planarization control, thin film measurements and alterations to eliminate peeling and cracking.
- Managed customer deliverables through the production line for on time delivery.
- Internal and external customer facing
0-5 years of experience
- Leads the process development of new optical connector designs
- Coordinates the project’s process strategy to deliver final optical performance
- Designs experimentation to ensure high performance of product while executing tasks to technicians
- Drives product and process transfers into offsite manufacturing plant through engineer and technician training
- Led the project team to develop a deeper level of fundamental understanding for innovative project to provide high cost savings to the company
- Demonstrated technical knowledge and problem solving skills to provide project a higher performing solution to existing products
- Oversaw and directed the work of a summer intern to execute a design of experiments for project
0-5 years of experience
- Developing the CBRITE Biosensor chipset process and cleanroom production pilot line
- Managing Biosensor wafer production w/ assistance of two technicians, delivering 1+ lots/ week to Biotechnology team
- Qualifying physical vapor deposition (PVD) systems for thin film metals and metal oxide semiconductors
- AJA Orion PVD metal sputter tool owner, assisting with process control, automation, and regular maintenance
- Karl Suss Mask Aligner 6 (MA6) lithography system tool owner, maintaining exposure intensity within +/-5% uniformity
- Assisting with HVAC, cleanroom, and service bay maintenance to ensure continuous wafer production operations
- Assisting with process development for side projects and X-Ray technology, as needed
0-5 years of experience
- Partner with product engineering and R&D to ensure effective new product and process introductions as well as consistent device performance and quality.
- Provide operational support to Cell R&D line with sustaining engineering efforts such as documentation, process engineering, SPC and continuous improvement.
- Responsible for Chemical Wet Bench sustaining engineering efforts that revolved around silicon wafer wet processing requirements such as damage etch, clean and texturing.
- Drove safety efforts to educate and train wet bench lab technicians to the hazards they face on a daily basis.
- Part of Metrology Team responsible for metrology tool maintenance and calibration in support of Next Generation Cell needs such as but no limited to IV testing, optical profilometry and SPC.
0-5 years of experience
- Performing fab process/tool trend data and correlation analysis to identify dog tools, trace defects to root cause, and rapidly take action to prevent inline process excursions
- Working cross-functionally with YE/PIE to develop defect reduction strategies and evaluating defect data on projected yield correlation
- Process improvement through systematic experimentation and hands-on approach to solving problems
- Ownership of projects related to yield, cost and throughput improvement involving work with manufacturing, R&D and equipment teams
0-5 years of experience
- Ensure successful launch of a new pharmaceutical drug, Eucrisa, at contract manufacturing organizations (CMO)
- Develop, execute and evaluate engineering studies at CMO’s to support scale up and transfer
- Provide on-site technical support at CMO’s during development, validation, and commercial batches
- Review CMO GMP documentation, including validation protocols/reports, executed batch records, change controls and CAPA’s, and deviations/notifications.
- Write technical reports to support product launch
- Draft and review relevant sections of PAS documentation
0-5 years of experience
- Coordinate electrode material fabrication operations
- Maintain electrode build pilot production
- Support the R&D electrode build team
- Use data to develop and implement continuous improvement plan for capability
- Prepare product/process reports by collecting, analyzing and summarizing information and trends
- Create and maintain standard operation procedure documentation
- Adjust/update machine settings and parameters for various product lines
0-5 years of experience
- Capital equipment acquisition and process transfer of new thin film plasma vapor deposition system
- Design, facilitization and startup of new pilot production department and thin film characterization lab
- Tribological analysis and surface finish development of hard and lubricious coatings on hard substrates
- Powder characterization and densification/sintering process transfer from R&D to production
- Developed powder specs; particle size distribution, GDMS, tap & bulk density, green & fired density
- Single crystal sapphire growth and recycling, characterization and finishing, safety steering committee
0-5 years of experience
- Work directly with designers, business units, marketing, packaging, Quality and manufacturing engineers
- Monitor and analysis of Process control Data from foundries
- Work with Product engineers to adjust Device specs based on manufacturer’s requirement to achieve highest yield
- Yield monitoring, probe results and data analysis
- Assist Product and test engineers on test program adjustments based on PCM
- Start, monitor and ensure the completion of process flow
- Review failure analysis reports
- Tape out new and changed designs to several different foundries
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[Process Development Engineer]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
