Technical Lead, Product Development

Role: Lead technical development for medical-device and combination-product projects, focusing on prototyping, feasibility, and design validation. Responsibilities: guide cross-functional teams in developing integrated product solutions, resolve complex technical challenges, and ensure compliance with design controls, risk management, and regulatory standards (ISO 13485, ISO 14971). Collaborate with electrical, software, human factors, quality, regulatory, and manufacturing teams to support hardware and software integration, testing, and validation. Qualifications: BS/BA with 14+ years, MS with 12+ years, or PhD with 6+ years in engineering, biomedical, or related discipline; proven expertise as a principal investigator, inventor, or author of patents/publications; demonstrated leadership in technical strategy and innovation. HighValue: medical devices, combination products, prototyping, design validation, risk management, regulatory compliance, cross-disciplinary collaboration. WorkSetup: not specified; extensive experience in regulated environments and technical leadership roles preferred.