Principal Systems Engineer/PDO

Principal Systems Engineer role serving as Product Design Owner for infusion pump systems at a medical device company. Responsible for technical oversight of electro-mechanical and software integration, regulatory compliance, and cross-functional collaboration throughout the product lifecycle.

Responsibilities

• Lead interdisciplinary design and development of infusion pump systems to meet regulatory standards
• Establish and maintain end-to-end system traceability, architecture, and product requirements
• Drive design reviews, risk identification, mitigation strategies, and compliance with design control procedures
• Make final technical decisions on product design and resolve competing constraints across engineering and cross-functional teams
• Manage design documentation, regulatory submissions, and audit preparation for product lifecycle

Requirements

• Bachelor's degree in engineering (Mechanical, Electrical, Software, or related field)
• 5+ years of experience in medical device design and development
• Demonstrated knowledge of FDA, EU MDR, ISO 13485, and medical device regulations
• Experience leading product transfers and design control processes
• 5+ years in medical device manufacturing industry (preferred)
• Ability to work with complex system traceability and risk management

Compensation: $112,000-$154,000 base annually