Risk Management Engineer

Fresenius Medical Care•Knoxville, TN

18h•Hybrid

About The Position

Provides technical expertise to the Risk Management Program and works with risk management and quality teams to maintain consistency and ensure procedures are followed. Ensures procedures are clearly defined and implemented to meet regulatory and business requirements for products and product lines assigned to the location or business unit. Develops and oversees the Risk Management Program for assigned business units, including product risk assessments and guidance on design and process FMEAs. Maintains compliant risk management files and documentation for manufactured, refurbished, and distributed products. Provides subject-matter expertise, direction, and training to staff and applicable departments; supports engineering teams and risk management review meetings; analyzes quality trends; and prepares reports for management. The role also supports investigations, harm and hazard analyses, and timely completion of Adverse Trend Investigation Reports and associated Corrective and Preventive Action recommendations. Ensures compliance with company procedures, FDA regulations and commitments, and applicable laws and policies. This is a hybrid position located in Knoxville, Tennessee, with approximately 10% travel.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Science, or a similar field.
Minimum 5–8 years of related experience in Risk Management and/or Quality Systems/Design Control in the medical device or pharmaceutical industries; 3 years of experience required with a Master’s degree.
English fluency.
Knowledge and application of quality systems, design controls, and risk management system requirements to comply with regulations and standards.
Effective leadership and influencing skills.
Teamwork and interpersonal skills.
Strong project management and organizational skills.
Excellent verbal and written communication skills.
Strong analytical and problem-solving skills.
Excellent attention to detail.
Resourceful, self-reliant, self-motivated, and confident.
Understanding and application of FDA and ISO audits.
PC-based computer skills, especially data management systems such as Access and Excel.
Approximately 10% travel.

Nice To Haves

Advanced degree.
Formal risk management training from a recognized training institution.
Certified Quality Engineer certification.
Bilingual English/Spanish.

Responsibilities

Ensure site compliance with risk management requirements and partner with Quality Systems staff to drive continuous improvement.
Develop and maintain risk management files according to applicable regulatory requirements and company policies and procedures.
Maintain risk management documentation for manufactured, refurbished, and distributed products in accordance with good documentation practices and the quality system.
Provide guidance and direction as the site subject-matter expert during risk management review meetings.
Provide risk management direction, training, and guidance to staff and applicable departments.
Analyze and report periodically on trends and other areas of quality data.
Develop, implement, and provide technical oversight of the Risk Management Program for assigned business units, including determining when and how to develop design and process FMEAs for manufactured products.
Facilitate the development and completion of product risk assessments.
Support and provide direction to engineering teams on risk management.
Ensure risk management and quality procedures are followed, defined, and implemented to meet regulatory and business requirements.
Provide guidance on analytical tools used to assess product failure investigations.
Establish a compliant reporting risk management system to support timely, accurate, and sustained decision-making.
Work with medical personnel to create appropriate harm and hazard analyses for issues that may affect patient outcomes.
Prepare reports for management summarizing activities, including trends and graphic presentations, as needed.
Complete Adverse Trend Investigation Reports (ATIRs) in a timely manner when required, including obtaining agreement and commitment to Corrective and Preventive Action (CAPA) recommendations.
Ensure product risk management files comply with company procedures and that FDA regulations and commitments are followed during process improvement activities.
Review and comply with the Code of Business Conduct, company policies and procedures, and applicable local, state, and federal laws and regulations.
Assist with projects assigned by a direct supervisor and perform other duties as assigned.
Maintain regular attendance and a good attendance record.