Operations-focused Program Engineer skilled in process optimization and navigating regulatory compliance across multiple sectors. Eager to contribute to healthcare advancements that improve quality of life. Seeking a Boston-based role and prepared to relocate immediately.
Overview
6
6
years of professional experience
Work History
Program Engineer
The Air-Conditioning, Heating, and Refrigeration Institute (AHRI)
Arlington, VA
08.2024 - Current
Managed execution of 600+ annual tests across five laboratories for 60 manufacturers to verify HVACR performance claims.
Coordinated laboratory audits and evaluated performance reports to ensure AHRI and ENERGY STAR compliance while serving as liaison between manufacturers and labs.
Led cross-functional industry committees to update AHRI program operations and performance standards.
Delivered technical training to new program engineers, ensuring seamless project transitions.
Led workflow automation initiatives and end-user training to improve operational efficiency and system adoption.
Regulatory Affairs Associate II
Proxima Clinical Research
Remote
12.2021 - 08.2024
Formulated regulatory strategies for life science companies to navigate FDA approval processes for medical devices, pharmaceuticals, and combination products.
Authored and refined regulatory submissions, including clinical trial protocols, Pre-Submissions, 510(k)s, De Novo requests, Breakthrough Device Designations, and Pre-INDs.
Collaborated with multidisciplinary client teams to analyze risk-benefit profiles and assess performance testing outcomes.
Product Engineer
Automated Industrial Technologies
Lynchburg, VA
08.2020 - 12.2021
Designed, fabricated, and tested automated machinery components to improve operational reliability.
Configured solid models, assemblies, and engineering drawings in SolidWorks using GD&T principles for enhanced manufacturability.
Developed standardized installation, operation, and quality assurance protocols to elevate product quality.
Education
B.S. - Engineering Science & Mechanics | Concentration in Biomechanics
Virginia Polytechnic Institute and State University
Blacksburg, VA
05-2020
Skills
Operations management
Regulatory compliance
Process optimization
Project coordination
Technical documentation
Risk analysis
Product development
Performance evaluation
Timeline
Program Engineer
The Air-Conditioning, Heating, and Refrigeration Institute (AHRI)
08.2024 - Current
Regulatory Affairs Associate II
Proxima Clinical Research
12.2021 - 08.2024
Product Engineer
Automated Industrial Technologies
08.2020 - 12.2021
B.S. - Engineering Science & Mechanics | Concentration in Biomechanics
Virginia Polytechnic Institute and State University