Sr Engineer; Systems-Risk

Job Summary

The Sr Engineer (Systems-Risk) is a Systems Engineer with expertise managing product risk documentation for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer has responsibility for risk assessments and documentation for the Ivenix Infusion System during the product development process and throughout the product lifecycle. This role works cross-functionally with engineering, test, quality, manufacturing, regulatory, clinical, and human factors team members to ensure appropriate risk identification and mitigation and documentation of those activities.

Salary Range: $145,000 - $155,000. Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Hybrid role:
Onsite 3 days per week. Applicants must be authorized to work for any employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

• 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 advanced 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.
• Works 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 provides advice and assistance to team members regarding routine and unique problems. May supervise or direct Sr engineers and lower-level engineers on assigned projects.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety,…