Hybrid Senior Principal Engineer – Systems-Risk

at Fresenius Kabi USA

• Job title: Senior Principal Engineer – Systems-Risk
• Job type: Full Time
• Experience level: Senior
• Salary: $145,000 - $160,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, North Andover, United States

About the role

• Systems Engineer specializing in risk documentation for medical device development. Collaborating with R&D teams to ensure compliance with industry standards across product lifecycle.

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

Requirements

• 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
• Development of FDA governed medical devices compliant with ISO 13485, ISO 14971 and IEC 62304 preferred
• 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

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental and vision coverage