Fresenius Kabi USARemote
Principal Engineer (Systems, Requirements)
United States of America
Full Time
2 hours ago
$105,000 - $115,000 USD
No H1B
Key skills
Systems engineeringSystemsubsystem requirements developmentMedical device product developmentRegulated industry product developmentFDA medical device regulationsISO 13485ISO 14971IEC 62304Risk managementArchitecture reviewVerificationvalidation (V&V) strategyPost-market surveillanceRoot cause analysisProblem-solving toolsIndependent judgmentRRisk Management
About this role
Fresenius Kabi USA is seeking a Principal Engineer specializing in Infusion Systems. This role involves developing and managing system requirements for medical devices, collaborating with various teams to ensure compliance with regulatory standards throughout the product lifecycle.
Responsibilities:
- Develops system- and subsystem-level requirements for medical devices that include electromechanical hardware, software, disposables, and labeling
- Reviews systems engineering related processes and ensures they are current with industry standards and regulatory requirements
- Contributes to other R&D system engineering activities as needed including risk management, architecture review, V&V strategy, and post-market surveillance
- Keeps abreast of new developments in the industry and translates those developments into new and viable options for the organization and customers
- Investigates issues to determine root cause using established problem-solving tools
- Ensures that research and design methodologies meet established scientific and engineering standards
- Participates in design activities to ensure overall system performance is considered in product design decisions
- Presents technical information in a clear and precise manner
- Works independently with latitude for individual judgment. Exercises judgment within defined procedures and practices to determine appropriate action
Requirements:
- B.S. degree in Engineering or related field
- Minimum of 5 years of related experience or equivalent combination of education and experience
- Experience with product development within a regulated industry
- A solid understanding of theories and practices utilized by other disciplines outside of primary area of expertise
- Strong verbal and written communications skills
- Ability to operate independently and exercise good judgement
- Development of FDA governed medical devices compliant to ISO 13485, ISO 14971 and IEC62304