Robert Keilty
Waltham
Summary
Dynamic Sr Reliability Engineer with over 10 years of experience in quality assurance, risk assessment, and reliable product development, particularly in the medical device sector. Proven track record of facilitating continuous process improvements, conducting thorough data analysis, and executing robust testing methodologies, including HALT testing, to meet reliability goals. Successfully led root cause analyses and developed initiatives that improved product safety and compliance. Eager to leverage expertise in reliability engineering to enhance product quality and operational excellence at forward thinking organizations.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Sr Reliability Engineer/Lab Manager
Amazon Robotics
North Reading, MA
05.2024 - Current
- Facilitated continuous process improvements within the Product Assurance Reliability group, focusing on tools, data analysis, system modeling, risk assessment, and maintainability analyses.
- Collaborated with the design team to formulate a comprehensive test plan for new product introductions (NPI) that are aligned with design and quality standards.
- Devised detailed reliability test plans to ensure appropriate testing methodologies and sample sizes were employed to validate product reliability goals.
- Analyzed and translated complex data into reliability predictions using statistical tools and methodologies to evaluate product performance under diverse conditions, including HALT testing.
- Partnered with product engineers to define reliability requirements, create decompositions, and develop programs, including setting benchmarks and performing system modeling for new products.
- Instituted a detailed reliability plan that documented necessary tasks, methods, tools, tests, and analyses to ensure alignment with safety and reliability objectives in the product development process.
- Conducted FMEAs, MTBF, and RCAs in collaboration with teams on new products to assess potential design issues and recommend enhancements to improve reliability, safety, and maintainability.
- Led product design reviews throughout the product development cycle, providing subject matter experts with insights on the reliability aspects of design and manufacturing processes.
- Executed root cause analysis for reliability issues using a data-driven approach and developed solutions to mitigate future failures. Ensured adherence to current regulations and standards related to laboratory safety and compliance for all relevant operations.
- Coordinated with contractors to address evolving requirements and needs for testing and prototype builds.
Sr Quality Engineer
LEDVANCE
Wilmington, MA
01.2026 - 05.2026
- Executed electrical and physical failure analysis (PFA) on electro-mechanical components and sub-assemblies.
- Performed rapid root cause analysis on field returns and forwarded the findings to the supplier/design, manufacturing teams.
- Investigating problems and developing disposition and corrective actions (CAPA) for recurring discrepancies.
- Maintained a comprehensive failure mode database in Excel, tracking defect trends to influence key manufacturing process changes.
- Traveled to China to review the suppliers testing and validation methods and made recommendations for continuous improvement.
- Performed audits and evaluations.
- Required the supplier to perform an 8D Model for corrective actions.
Quality validation
THERMOFISHER SCIENTIFIC
Lexington, MA
07.2023 - 05.2024
- Oversaw the review of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of process equipment.
- Participated in investigations and the evaluation of deviations to uphold quality standards.
- Authored and executed test scripts for Computer Systems Validation (CSV).
- Reviewed and endorsed Standard Operating Procedures to ensure compliance and quality.
- This contributed to team efforts by conducting Gemba walks to assess proficiency, safety, and GMP adherence throughout production cells and laboratories.
- I possessed familiarity with SAP and Track wise systems.
Sr Design Quality/Reliability Engineer
KUVA SYSTEMS
Cambridge, MA
01.2023 - 07.2023
- Instituted a system for Device History Records (DHRs), calibration records, MRB processes, CAPA processes, and ISO9001 preparation, essential for tracking product lifecycle, maintaining compliance, and addressing potential issues.
- Collaborated with the design team to ensure products met stringent quality standards throughout their design and development lifecycle, emphasizing regulatory compliance and continuous risk management improvement.
- Engaged with cross-functional teams to identify and resolve design challenges, contribute to design control activities, and support the development of robust and reliable products.
- Executed inspections of incoming raw materials, components, and products, confirming adherence to required specifications and quality standards before production phases.
- Implemented a Supplier Quality Control System:
- Supplier Assessment: Conduct regular supplier audits and assessments to ensure compliance with quality, regulatory, and company standards.
- Quality Management: Develop and implement incoming inspection plans, quality control plans, and supplier quality agreements.
- Defect Resolution: Lead root cause analysis (RCCA) for supplier-related defects, initiating Supplier Corrective Action Requests (SCARs) and verifying corrective actions.
- Supplier Development: Collaborate with suppliers to improve process capabilities, reduce defect rates, and enhance quality performance.
- Product Development Support: Work with design teams to define part specifications, tolerances, and quality standards for new products.
- Performance Tracking: Monitor supplier performance metrics (e.g., quality rating on time delivery) and report findings to management
- Established reliability programs, including DFMEA, CV & DMA, RCA, HALT, and HASS, enhancing product reliability efforts.
- Performed both internal and vendor audits/inspections to ensure adherence to quality standards and practices.
- I implemented a 5S Lean Workplace initiative and developed a calibration program for both electrical and mechanical measuring devices.
Sr Validation Engineer (Class II Medical Device) (Contractor)
OLYMPUS CORPORATION
Westborough, MA
08.2020 - 01.2023
- Contributed to the development of innovative and high-quality medical devices, particularly disposable endoscopes.
- Fabricated test fixtures carried out product testing and generated comprehensive documentation and SOPs to support product development and fulfill regulatory requirements.
- Participated in the DFMEA review team, identifying potential failure modes and proposing design modifications to mitigate risks and enhance product reliability.
- Traveled to contract manufacturers to observe their processes, identify previous build issues, and offer guidance for process enhancements. Assisted with record updates to maintain compliance with EU-MDR regulations.
- Performed key validation criteria for the development of the disposable endoscope:
- Verification: Confirming the product is built correctly against design inputs (e.g., prototypes, simulations, software requirements).
- Validation: Confirming the correct product was built, ensuring it meets customer requirements and intended use.
- Testing: Developing and executing test cases, debugging, and performing hardware-software integration tests.
- Documentation: Producing detailed reports, technical manuals, and maintaining documentation related to quality standards.
- Tooling/Automation: Creating automated scripts to speed up testing and ensure test equipment is calibrated.
- Conducted assembly and testing of electronic boards, supporting the micro camera and lumens output of the endoscope to ensure optimal operation.
- Proficient in Design of Experiments (DOE), Operational Qualification (OQ), and Gage R&R, and performed pull and peel testing using Instron and Zwick/Roell devices.
Reliability/Quality Engineer (Class II Medical Device) (Contractor)
ZOLL MEDICAL
Chelmsford, MA
01.2020 - 08.2020
- Implemented rigorous CAPA processes to identify, investigate, and rectify non-conformances, preventing recurrence and upholding product quality.
- Managed the calibration system to ensure accurate and reliable measurements, ensuring compliance with quality standards.
- Established a Highly Accelerated Stress Screening (HASS) process for finished ventilators, guaranteeing product quality and reliability.
Reliability Engineer/Lab Manager (Class II Medical Device)
CSA MEDICAL
Lexington, MA
05.2013 - 12.2019
- Executed reliability program implementations, featuring component and system-level testing using shock, vibration, environmental, and EMC testing to assure product quality and durability.
- Authored protocols to comply with IEC 60601 3RD and 4TH editions, ensuring adherence to electrical safety standards.
- Conducted off-site EMI and EMC testing, in addition to HALT testing, to validate product performance.
- Assisted in the design, development, and construction of test fixtures, showcasing strong soldering skills with thru hole and surface mount components.
- Operated within a controlled cleanroom environment, adhering to stringent cleanliness and hygiene protocols to maintain product quality and safeguard against contamination in catheter development.
- Utilized CMM (Mitutoyo) for precise measurements and quality control. Led the relocation of our lab to a new facility, expanding from 1,600 sqft to 11,000 sqft, optimizing operational efficiency.
- Coordinated with contractors for the setting up of the new lab and logistics for moving lab and office equipment.
- Designed and executed validation testing on both the device and the catheter.
- Trained personnel on operating power tools and machine shop equipment and provided training on handling gases and LN2.
- Oversaw the calibration and preventive maintenance scheduling of equipment, ensuring operational readiness.
- Maintained comprehensive records of facility operations, maintenance, and contracts.
- Supervised renovations, upgrades, and other facility projects, employing Facility Management CMMS tools to manage and optimize maintenance activities while tracking assets to improve efficiency.
Reliability Engineer (Class II Medical Device)
DRAGER MEDICAL
Andover
10.2011 - 05.2013
Sr. Field Service & Clinical Engineer (Class III Medical Device)
INFRAREDX CORPORATION
Burlington
05.2007 - 08.2011
Design Quality Engineer
MEDISPECTRA
Lexington
04.2005 - 04.2007
Reliability Engineer
NUVERA FUEL CELLS
Cambridge
08.2001 - 04.2005
Education
Bachelor's degree - electrical engineering
ITT Technical Institute
Boston05-1987
Skills
- Reliability Engineering
- Validation Engineering
- Quality Engineering
- Test Engineering
- System Specification
- Process Validation
- Equipment Validation
- Computer System Validation (CSV)
- 21 CFR Part 11
- Validation Protocols (IQ, OQ, PQ, and Cleaning Validations)
- Statistical Summaries, Final Reports, And Deviation Investigations
- ISO 9001, 13485, and FDA Regulations
- OSHA Training
- 8D Training
- GD&T
- 5S
- IPC 610
- GMP CFR 820
- GXP
- Predictive Maintenance
- Lifecycle Asset Management
- Statistics and Probability
- End-to-end Validation Deliverables
- Risk Management
- Agile
- LabVIEW
- Excel
- Calipers
- Micrometers
- Height gauges
- Oscilloscopes
- Volt meters
- Analyzers
- Electrical and mechanical systems
- SAP
- Trackwise
- DFMEA
- CV & DMA
- RCA
- HALT
- HASS
- DOE
- Gage R&R
- Pull & peel testing
- Instron
- Zwick/Roell devices
- IEC 60601 3RD and 4TH editions
- EMI and EMC testing
- CMM (Mitutoyo)
- Facility Management CMMS
- Project Management
- Problem Solving
- Communication
- Software Development Life Cycle (SDLC) Methodologies
- Requirement Gathering
Certification
- Requirement Gathering Mathematics/Probabilities Certificate Course Lowell Institute @MIT
- Certificate in Reliability Engineering RIAC (Reliability Information Analysis Center)
- IPC 610 soldering for both Commercial & MIL Specs
- Green Belt Certification Six Sigma Training
- OSHA Safety & Health Certification
- ASQ Certification
- FMEA & Component Derading Training
Timeline
Sr Quality Engineer
LEDVANCE
01.2026 - 05.2026
Sr Reliability Engineer/Lab Manager
Amazon Robotics
05.2024 - Current
Quality validation
THERMOFISHER SCIENTIFIC
07.2023 - 05.2024
Sr Design Quality/Reliability Engineer
KUVA SYSTEMS
01.2023 - 07.2023
Sr Validation Engineer (Class II Medical Device) (Contractor)
OLYMPUS CORPORATION
08.2020 - 01.2023
Reliability/Quality Engineer (Class II Medical Device) (Contractor)
ZOLL MEDICAL
01.2020 - 08.2020
Reliability Engineer/Lab Manager (Class II Medical Device)
CSA MEDICAL
05.2013 - 12.2019
Reliability Engineer (Class II Medical Device)
DRAGER MEDICAL
10.2011 - 05.2013
Sr. Field Service & Clinical Engineer (Class III Medical Device)
INFRAREDX CORPORATION
05.2007 - 08.2011
Design Quality Engineer
MEDISPECTRA
04.2005 - 04.2007
Reliability Engineer
NUVERA FUEL CELLS
08.2001 - 04.2005
Bachelor's degree - electrical engineering
ITT Technical Institute