Results-driven R&D Engineer with expertise in product development, regulatory compliance, and device testing. Proven ability to execute comprehensive testing, facilitate project transitions, and ensure FDA compliance.
Overview
27
27
years of professional experience
Work History
R&D Engineer
DORC
Doylestown
12.2025 - Current
Executed all phases of product assembly for development and testing.
Developed innovative products, including laser probes, light pipes, and forceps.
Provided prototypes and samples for customer evaluations and trials.
Submitted 510(k) applications to FDA for device approval.
Conducted comprehensive device testing for data collection and reporting.
Created and edited device drawings using CAD software such as Solidworks and AutoSketch.
Designed and 3D printed component prototypes and fixtures for production.
Requested quotes and issued purchase orders to vendors for necessary components.
Created comprehensive manufacturing documents to facilitate production processes.
Transferred projects to production while ensuring seamless handover.
Trained assemblers on new processes to enhance operational efficiency.
Resolved end user issues related to file access, email, hardware, and printing.
Configured new employee laptops and conducted training on their use.
Troubleshot network issues to maintain optimal performance.
Addressed production-related computer problems in a timely manner.
Collaborated with IT consultants on service tickets and followed up on resolutions.
Facilitated monthly planning calls with DORC IT team for upgrades and integrations.
Served as local contact for DORC and Zeiss IT-related visits and upgrades.
Procured all necessary IT hardware and software to support operations.
Oversee management of all company data.
Coordinated scheduling of multiple vendors for building services and maintenance, including HVAC and electrical systems.
Conducted walkthroughs with vendors to assess service requirements.
Requested estimates and quotes from vendors, issuing POs for necessary work.
Assisted Quality and Regulatory teams with DCNs and complaint resolutions.
Inspected devices returned by customers to diagnose issues.
Reviewed DCNs and uploaded updated files to shared drive.
Facilitated audit preparation, execution, and response management.
Created and printed product labels for compliance purposes.
Coordinated translation services for labels and IFUs.
Collaborated with customers to perform and submit label revisions.
Trained personnel on process validations and shipping tasks.
Maintained accurate data records in FDA GUDID database.
Prepared comprehensive data for EUDAMED submission.
Assisted with various MDR-related tasks to ensure compliance.
Completed CAPA responses to address regulatory requirements.
Manager
UPS
New Hope
05.2005 - 10.2010
Supervised daily operations and ensured compliance with safety standards.
Trained new employees on operational procedures and best practices.
Monitored inventory levels and ordered supplies as needed for efficiency.
Enforced customer service standards and resolved customer problems to uphold quality service.
Completed thorough opening, closing, and shift change functions to maintain operational standards each day.
Executed billing processes for customers and secured payments
Client Services Associate
Lookaway Golf Club
Buckingham
04.2001 - 10.2004
Delivered exceptional customer service to members and guests at private golf club.
Provided course strategy, club selection advice, and yardage analysis to enhance gameplay.
Managed equipment effectively while maintaining pace of play under pressure.
Facilitated tournament setup processes
Customer Service Representative
Wawa
Buckingham
06.1999 - 09.1999
Assisted customers with product inquiries and order placements.
Processed cash and card transactions accurately at the register.
Maintained cleanliness and organization of the service area.
Stocked shelves with fresh products, ensuring high-quality presentation.
Education
Some College (No Degree) - Engineering / Information Sciance
Villanova University
Villanova, PA
Skills
Product development
Device testing
FDA compliance
CAD design
Prototype creation
Regulatory documentation
Timeline
R&D Engineer
DORC
12.2025 - Current
Manager
UPS
05.2005 - 10.2010
Client Services Associate
Lookaway Golf Club
04.2001 - 10.2004
Customer Service Representative
Wawa
06.1999 - 09.1999
Some College (No Degree) - Engineering / Information Sciance
Global Medical Director at Dutch Ophthalmic Research Center (DORC) InternationalGlobal Medical Director at Dutch Ophthalmic Research Center (DORC) International