Jobs at Status Pro

Leads quality assurance, regulatory compliance, audits, CAPA and nonconformity closure for operational units. Reviews device records, monitors incoming-goods quality, supports multidisciplinary improvement initiatives, and applies root-cause and statistical quality tools. Maintains compliance with FDA QSR, ISO 13485, and company procedures while coordinating with production, suppliers, and management.

Develops and maintains manufacturing documentation, trains personnel, improves yield and output, analyzes field and test data, implements product and process changes, and collaborates with supply chain, design, and purchasing teams. The role supports complex assembly and testing for medical devices and requires electrical engineering expertise, ESD and IPC soldering knowledge, multidisciplinary project experience, and continuous improvement skills.

Leads multidisciplinary product development teams and owns product functionality, system architecture, design, testing, release, requirements traceability, risk analysis, and FMEAs. Coordinates mechanical, electrical, and software development, mentors engineers, and supports products from concept through launch and lifecycle management. Requires medical device development experience, FDA-regulated engineering design, cross-functional technical leadership, supplier communication, and integration of electrical components into mechanical systems. International travel of approximately 10% is expected.

Develops and releases service documentation, spare-parts requirements, training content, and serviceability tests for medical device subsystems. Supports helpdesk resolution of field issues, validates engineering changes for service impact, and improves serviceability, reliability, and workflows using Lean methods. Collaborates with cross-functional NPI and R&D teams, training centers, and customer service organizations while transferring technical knowledge and incorporating field feedback.