Fresenius Kabi USA · 9 hours ago
Sr Principal Engineer (Systems-Risk)
North Andover, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$145K/yr - $160K/yr
8+ years expFresenius Kabi USA is seeking a Sr Principal Engineer in Infusion Systems, who will manage product risk documentation for medical devices and collaborate with the R&D team. The role involves conducting risk assessments, ensuring compliance with industry standards, and working cross-functionally to support product development throughout the lifecycle.
Health Care
No H1B
Responsibilities
Leads the development and revision of all product risk documentation per current industry standards and regulatory requirements
Collaborates with cross-functional team members to build Use and Design Failure Modes and Effects Analyses (FMEAs) and Risk Assessments
Identifies, and verifies effectiveness of, risk control measures throughout the product lifecycle
Reviews Process FMEAs developed by contract and internal manufacturing teams
Investigate issues to determine root cause using established problem-solving tools
Leads Risk Management Committee meetings as appropriate, preparing information to be presented and capturing and tracking action items to closure
Drives compliance with internal risk processes and creates or refines tools and templates to ensure compliance per ISO 14971 and other standards and regulations
Develops and updates the Safety Assurance Case in collaboration with Clinical Product Specialist, Human Factors Engineering and Regulatory Affairs
Contributes to other R&D system engineering activities as needed including requirements management, architecture review, V&V strategy, and post-market surveillance
Provides training as needed when significant changes are made to risk processes
Participates in design activities to ensure risk reduction is considered in product design decisions
Contributes to risk strategies for new product feature development
Participates in Usability Engineering activities
Works independently with latitude for individual judgment. Exercises judgment within defined procedures and practices to determine appropriate action
Qualification
Required
B.S. degree in Computer Science or related field
8+ years of related experience or equivalent combination of education and experience
Experience with product development within a regulated industry
Experience with conducting and presenting risk analyses
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
Preferred
Development of FDA governed medical devices compliant with ISO 13485, ISO 14971 and IEC 62304 preferred
Benefits
401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits to include medical, prescription drug, dental and vision coverage
Life insurance
Disability
Wellness program
Company
Fresenius Kabi USA
Fresenius Kabi is health care company specializing in medical and medical technologies.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Alex Garini
Chief Financial Officer
Sanjida Chowdhury
Vice President and Chief Compliance Officer, Region US
Recent News
Business Standard India
2025-10-23
Research and Markets
2025-08-05
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