Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives.

Position Summary:

The IT Process Engineer is responsible for the overall quality of the Information Technology (IT) Governance process and oversees the functioning of and compliance with the procedures, policies, and technologies associated with IT Governance. They have a focus on improvement in support of the organization’s information technology resources, policies and procedures.  In addition, the process engineer is responsible for the management of business case submissions to the IT Governance committee.  This includes timely response to business case submitters, submission tracking, scheduling business case review and reporting to the company.  The IT Process Engineer will interact with staff and leaders across the organization to determine current efficiencies and improvement opportunities.  The IT Process Engineer with work with and educate business owners in the effective study and improvement of their business processes.

Principal Duties Responsibilities: 

• Work closely with IT leadership to create and maintain procedures vital in the support of the System Development Life Cycle.
• Liaise with BBraun North America and our European parent companies to ensure technical and procedural alignment between the organizations.
• Promote and reinforce adherence to the process and policies associated with the IT Governance Policy
• Owns the Technical Change Management Process and supporting documentation from a strategic and tactical perspective.
• Analyze, design, plan, manage, and improve the IT Governance policies and procedures.
• Facilitate teams to critically review current processes for effectiveness, quality and simplification.
• Participates in process improvement efforts of computer system policies, procedures and computer system validation processes.
• Responsible for maintaining, writing and updating IT / SAP department procedures and policies, procedure, system security and standard operating procedures.
• Represent Aesculap’s interests and works with Global Teams in the alignment and adherence to Corporate IT Governance Policies.
• Work with business owners to identify process challenges by analyzing process data and metrics.
• Develop standardized procedures and templates for Feasibility Studies, Cost Benefit Analysis and Return on Investment calculations and execution.
• Working knowledge and experience in process definition and improvement methodologies
• Must comply with applicable ISO and FDA regulations as stated in Quality Manual
• Must embody the Company’s Vision, Mission and Values
• Other duties may be assigned

 Secondary or peripheral job functions: 

• Train business and IT users on IT Governance and IT Process and Policy.
• Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
• Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
• Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

 Supervisory Responsibilities: N/A

Education / Experience

• Bachelor degree in computer science or related discipline from four year college or university; or equivalent combination of education and experience required.
• 2 to 4 years’ experience in Computer System Validation and change management of computerized systems preferred.
• Experience with ITIL Best Practices preferred but not required
• Previous experience in a Quality Change Management or IT organization, supporting systems in a Medical Device or Pharmaceutical industry preferred.
• Well versed in system lifecycle processes and methodologies, with emphasis on quality assurance and testing best practices (e.g. GAMP5, 21 CFR Part 11 and IEEE).
• Experience in creating and revising Standard Operating Procedures to meet the ever-changing Information Technology Environment.
• Experience with SAP or other Enterprise systems.
• Working knowledge of MS Office applications.
• Good communication, presentation and technical writing skills.
• Ability to multi-task and deal with changing deadlines and priorities. Be proactive and identify potential computer system validation issues and prevent adverse results.
• Ability to interact and partner with diverse functional and technical groups, spanning all organizational levels locally and globally.
• Knowledge of technology processes and regulatory requirements (both FDA and EMEA).
• Demonstrate logic and good problem solving / decision making skills with ability to participate in the resolution of complicated system issues.
• Ability to grasp new concepts and skills quickly and adjust process and procedures as necessary.
• Willingness to assume new responsibilities, and initiatives, as well as keep current with FDA initiatives and new regulations.
• Ability to deal effectively with internal employees and external business contacts while conveying a positive, service-oriented attitude.
• Ability to work with minimal supervision, managing own time effectively. Be available for duties on weekends and off-hours.

Language and mathematical skills; reasoning ability:

• Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to effectively present information to top management, public groups, and/or boards of directors.   
• Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. 
• Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Responsibilities: Other Duties:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms.  The employee is occasionally required to stand and walk.  The employee must occasionally lift and/or move up to 30 pounds. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.

Equal Opportunity Employer Veterans/Disabled