About this Candidate
DAVRON CV: Candidate 1859300
MEDICAL DEVICE PROGRAM & ENGINEERING LEADER | NPD · NPI · MANUFACTURING TRANSFER
Core Expertise
- Program leadership for global medical device development, NPD/NPI, and manufacturing transfer programs.
- Driving regulatory compliance with FDA, ISO 13485 and cGMP through design controls and technical documentation.
- Leading cross-functional teams across R&D, manufacturing, quality, regulatory, and supply chain to meet milestones.
- Developing SOPs, manufacturing/control plans, make-vs-buy analyses, and COGS estimates to ensure production readiness.
- Applying DFMEA/PFMEA, process validation, SPC, and CAPA systems to mitigate technical and manufacturing risk.
Project Background
- Managed labeling and packaging updates across multiple product lines to satisfy new regulatory requirements on schedule.
- Led supplier qualification and new material sourcing for coated implantable components, delivering validated production in 18 months.
- Directed verification and validation activities including PLC test rigs and SPC analyses to reduce test costs.
- Drove international spine and orthopedic product development from surgeon requirements through design freeze and market launch.
- Executed product transfers and control plan implementations across global manufacturing sites while managing change control.
Key Skills
- Creo | SolidWorks | CATIA | PDM systems
- MS Project | Excel | Office | MATLAB | Minitab
- SAP | Veeva | Kneat | Windchill | Trackwise
- Program & project management | Budgeting | Stakeholder reporting
- Design controls | DFMEA/PFMEA | Process validation | CAPA/NCMR
- Supplier engagement | Make-vs-buy analysis | COGS estimation
Education
- MBA — Jack Welch Management Institute (Welch Scholar)
- M.S., Mechanical Engineering — Drexel University
- B.S., Mechanical Engineering — Northeastern University
Awards & Recognition
- 17 patents granted
- PMP certification (in progress, expected 2026)
- Welch Scholar — MBA program
Why Interview this Candidate?
A hands-on engineering and program leader with 20+ years delivering regulated medical device programs from concept through commercialization. Proven ability to align design requirements to production controls, execute DFMEA/PFMEA and validation activities, and lead global cross-functional teams to on-time, compliant product launches. Brings technical depth in CAD and test development plus measurable cost and schedule outcomes.
LEARN MORE
If this sounds like a candidate that you'd like to speak with, contact us for more information. It's always free to review resumes and set up interviews! We only charge a fee if you hire one of our candidates. Not who you are currently searching for? Send us a job description and we will begin a dedicated search right away, at no obligation!