• Sr. Engineering Specialist utilizes technical domain knowledge to lead and guide team members involved in the design and development for solutions used for blood collection and cell processing, according to established engineering principles and relevant standards and regulations.
• Provide planning and leadership to ensure adequate resources are available to complete business unit and division responsibilities.
• Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures.
• Serve as subject matter expert and point person for cross-functional support and consultation.
• Identify risks and resolve issues that may negatively impact project scope, schedule, and budget.
• Develop staff members to grow technical expertise and project management capabilities.
• Create and maintain an environment where team members experience personal and professional growth and become a more self-directed team.
• Develop and maintain detailed documentation, for both internal and external customers, throughout all phases of product design development. Ensure that all design control / change control requirements are met.
• Develop product requirements, drawings, control specifications, medical device risk management files, and provide analysis of proposed designs to determine their ability to function as intended by considering use case scenarios and various other inputs.
• Create/maintain complex project schedules. Work with cross-functional team members to ensure timely and accurate completion of the project. Effectively communicate status and issues to management when they arise.
• Provide technical input to strategic/project plan while collaborating across organizational functions to achieve company and project objectives.
• Continually improve product performance, capabilities and identify risks to resolve issues that may negatively impact strategy/project scope, schedule, and budget.
• Effectively support team members in the creation and implementation of development plans; foster development by providing appropriate challenges for team members.
• Provide leadership to team members, guiding them in terms of prioritization, problem resolutions, process clarification, referrals to appropriate experts, etc. to ensure timely completion of responsibilities.

This job position within the MedTech R&D function of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

Requirements

*B.S. degree in Engineering (materials, biomedical, industrial, chemical or mechanical) with +10 years of specialized experience in the medical disposables/device products field or advance technical degree.

*Experience in compliant practices of design control and medical device risk management.

*Strong leadership and project management skills.

*Strong analytical capability and attention to detail.

*Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex

problems through innovative thought and experience.

*Ability to manage multiple cross-functional teams simultaneously.

*Ability to design and influence outside of immediate scope of responsibility.

*Proven track record of management/leadership effectiveness.

*Excellent analysis, troubleshooting, and debugging skills

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

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.