Ph.D. trained Mechanical Engineer with extensive experience leading the research, development, and post-market support of innovative medical instrumentation and defense technologies. Proven Technical Leader recognized for delivering creative solutions to complex engineering challenges and guiding cross-functional teams in high-stakes environments. Adept at navigating FDA and EU/MDD regulatory landscapes, driving compliance and quality from concept through commercialization.

Demonstrated success at top-tier global companies, balancing deep technical knowledge with strategic insight into market and industry trends. Currently seeking a new opportunity due to the planned relocation of current team overseas.

Core Competencies:

• Electro-Mechanical Instrumentation | Concept-to-Launch Product Development
• Structural FEA (Linear/Non-Linear) | CFD & Conjugate Heat Transfer Simulation
• Technical Project Leadership | Technology Transfer & Cross-Functional Collaboration

Regulatory Compliance: 

• FDA QSR (21 CFR 210, 211, 820, 821, 822, 11)
• ISO 13485, ISO 14971, ISO 11608-1/3
• IEC 60601-1
• CE Marking

Quality Systems:

• CAPA, Non-Conformance (NC)
• Escalation Field Complaint (PM) Management

Candidate seeks a formative role in the NorthEast.