Senior Principal Engineer – Systems-Risk
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: North Andover • Massachusetts • New Hampshire • United States
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Salary
💰 $145,000 - $160,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk documentationFailure Modes and Effects Analyses (FMEAs)Risk Assessmentsroot cause analysisISO 14971ISO 13485IEC 62304requirements managementverification and validation (V&V)Usability Engineering
Soft Skills
collaborationproblem-solvingcommunicationindependent judgmenttrainingleadershiporganizational skillsattention to detailaction item trackingadaptability