Senior Principal Engineer, Infusion Systems

Fresenius Kabi USA

. Leads the development and revision of all product risk documentation per current industry standards and regulatory requirements.

Posted 5/7/2026full-timeNorth Andover • Massachusetts • 🇺🇸 United StatesSenior💰 $145,000 - $155,000 per yearWebsite

About the role

Key responsibilities & impact

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 risk management processes with other business units and leads adoption of best practices.
Reviews Process FMEAs developed by contract and internal manufacturing teams.
Participates in Risk Management Committee meetings, preparing information to be presented and capturing and tracking action items to closure.
Leads compliance with, and continuous improvement of, internal risk processes
Develops and updates the Safety Assurance Case in collaboration with Clinical Product Specialist, Human Factors Engineering and Regulatory Affairs.
Performs additional R&D system engineering activities as needed including requirements management, architecture review, V&V strategy, and post-market surveillance
Leads post-market surveillance activities to maintain accurate, updated risk management files including responsibility for MAUDE database reviews, complaints analysis and CAPAs ownership.
Uses computer-based tools to manage versions of risk objects and traceability to requirements and specifications.
Displays advance understanding of theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions and performance.
Evaluates results relative to product requirements, definitions and/or program goals.
Applies standard techniques to solving difficult problems.
Work independently with latitude for individual judgment.
Exercises judgment within defined procedures and practices to determine appropriate action.
Guides the conceptualization of new methodologies, materials, machines, processes or products.
Generates innovative solutions to complex problems through the use of multiple disciplines and technical principles.
Advise senior management regarding appropriate action.
Works on solving complex issues within department, where analysis of situations or data requires an in-depth evaluation of variable factors.
Erroneous decisions or failure to achieve goals may result in additional costs and serious delays in overall schedules.
Routinely provide advice and assistance to team members regarding routine and unique problems.
May supervise or direct Sr engineers and lower-level engineers on assigned projects.

Requirements

What you’ll need

Bachelor’s Degree in Engineering or similar related degree.
8 years’ experience in a related role achieving similar responsibilities within the medical device industry.
Comprehensive understanding of the medical device development process.
Excellent interpersonal skills including ability to work effectively in a matrix environment.
High attention to detail and excellent oral and written communication skills.
Excellent problem solving and organizational skills.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

risk managementFMEArisk assessmentrequirements managementarchitecture reviewverification and validation (V&V)post-market surveillanceCAPAsafety assurance casemedical device development

Soft Skills

interpersonal skillsproblem solvingorganizational skillscommunication skillsjudgmentcollaborationinnovationleadershipattention to detailindependent work