Benjamin Duncan Email & Phone Number

• Lead Consulting/Staffing projects related to computer system implementation, design quality engineering, manufacturing, validation, and continuous improvement for clients.• Serve as subject matter expert for Design Control, Risk Management, V&V Testing for internal and external technology implementation projects.• Provide strong leadership support to internal project teams, ensuring the delivery of high-quality outcomes within specified timelines and budgets.• Contribute to the creation and delivery of proposals, assessments, and reports for new projects and partnerships. Monitor project progress, identify risks, and implement corrective actions to ensure successful project completion.

• Spearheaded core R&D team consisting of 3 junior engineers and 2 co-op students responsible for test engineering of optical coherence tomography (OCT) intravascular catheters, opto-electro-mechanical console and AI-enabled software. • Collaborated closely with R&D, Quality, Manufacturing, Clinical & Marketing teams to determine testing requirements.• Formulated sophisticated test plans ranging from R&D investigations to formal design verification and validation accounting for product specifications, risk analyses, and nuances of product performance. • Built benchtop models capable of evaluating many aspects of product performance and reproducing field failures.

• Managed R&D subgroup of 2 junior engineers and co-op students responsible for OCT catheter and systems testing.• Devised and executed complex test plans, validations, and failure investigations. • Authored 30+ novel test methods ranging from mechanical tests to image analyses. Undertook software and hardware verification activities. • Presented product demos for visiting physicians, subject matter experts and industry colleagues highlighting intricate design.• Developed Python and MATLAB scripts for image processing.

• Managed team of junior engineer and interns overseeing sustaining engineering activities for a marketed medical device and new product development.• Led benchtop design verification and validation studies of an intravascular imaging system. Performed regression analyses on design changes, evaluated prototypes, developed specifications, and informed risk analyses to enhance product quality.• Designed and executed over 20 required protocols in line with product specifications, risk analyses, regulatory requirements, and international standards. • Supported Manufacturing and Quality teams through commercialization assisting with Process Validation, Equipment Qualifications, and Test Method Validations.

United States

• Joined small start-up team quickly integrating as a core team member. Worked cross-functionally with Engineering, Quality, Regulatory, and Operations teams to achieve company’s first regulatory clearances. • Formulated verification and validation plans for FDA and PMDA (Japan) submissions of disposable OCT intravascular imaging catheter and opto-electro-mechanical console. Optimized sampling plan saving the company $100k.• Designed 20+ custom test fixtures. Validated equipment in conformance with company’s SOPs.

United States

• Devised benchtop neurovascular flow model and validated contrast flushing protocols for an intravascular catheter. • Assisted in image acquisitions during in vivo animal studies. Operated the imaging console and troubleshot software and hardware issues as they arose. • Generated software tools for automated feature detection in 500+ frame images.Devised benchtop neurovascular flow model and validated contrast flushing protocols for an intravascular catheter. • Assisted in image acquisitions during in vivo animal studies. Operated the imaging console and troubleshot software and hardware issues as they arose. • Generated software tools for automated feature detection in 500+ frame images.

Conflans-Sainte-Honorine, France

• Developed solutions to manufacturing and quality control problems • Wrote cahier des charges (project specification reports) in both French and English detailing needs, functions, and constraints of solutions to problems• Presented recommendations to group of managers, highlighting benefits, cost, challenges and timeframe

Woods Hole, Ma

Sectioned and analyzed sediment cores taken from Marshall Islands for radioactive isotopes. Cut cores, detected Gamma rays, and analyzed radiochemistry in samples. Presented final work to Senior Scientists and fellow guest students

Worcester, Ma

Collected and entered data electronically for project researching doctor-patient empathy. Implemented research methodology and design, recruited patients for study, and compiled data for final paper.

Graduate Certificate, Human Factors In Data Science

The Human Factors in Data Science certificate program provides students with the knowledge and skills to engage in the design.

Bachelor Of Science (B.S.), Biomedical Engineering

Activities and Societies: Alpine Ski Team