ENGINEER II, SYSTEMS

About Company:

A forward-thinking healthcare company focused on advancing the industry through intelligent, innovative, and differentiated respiratory solutions. The company is committed to improving patient outcomes by combining cutting-edge technology with user-centered design, while maintaining strong emphasis on quality, compliance, and clinical effectiveness

An Ideal Candidate:

An ideal candidate who leads end-to-end product technical success, with strong expertise in system architecture, requirements development, and cross-domain integration across hardware, software, and firmware. Demonstrates solid understanding of medical device regulations, ensuring compliance through rigorous documentation, verification and validation, and usability engineering. Effective cross-functional collaborator, supporting audits, external testing, and post-market activities while aligning teams across R&D, quality, design, and regulatory functions.

Key Competencies:

• Strong knowledge of medical device technology, quality standards (ISO 60601), and regulatory requirements (FDA, MDD)
• Experienced in requirements management, traceability, and Design History File (DHF) documentation
• Skilled in risk management (ISO 14971) and usability engineering practices
• Proficient in engineering change control and impact assessment processes
• Effective in fast-paced environments with multiple projects and competing priorities
• Strong analytical, problem-solving, and communication skills
• Knowledge of product lifecycle management, GDP, and GMP practices
• Collaborative team player with focus on quality, compliance, and continuous improvement