Principal Systems Engineer/PDO
Baxter · Round Lake, IL
IT & SoftwareFull-time$112k–$154kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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