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 (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. 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.

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 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.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

•     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.
 

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.