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:

Works with Engineering, Marketing, Quality, Regulatory, and other key stakeholders to ensure US market and regulatory requirements are met during the design of a product.

 

Principal Duties Responsibilities: 

                   

• Works with cross-functional teams including Marketing, Production, Quality, Regulatory, and R&D to develop design history files (DHF) of medical devices.
• Provide expertise on product design and optimal design specifications.
• Able to lead cross-functional teams to complete medium and large sized projects with moderate management supervision.
• Responsible for interpreting and applying appropriate standards and regulatory guidance to new and existing medical devices.
• Responsible for defining appropriate test strategies and executing testing either internally or with 3^rd party vendors.
• Organizes and leads meetings to plan and track project progress.
• Works to quality system regulation design control documents.
• Must comply with applicable ISO and FDA regulations as stated in the Quality Manual.
• Must embody the Company’s Vision, Mission and Values.
• Creates 3D models in CATIA V5.
• Transfers Models to 2D drawing.
• Dimension, tolerance and complete drawing to standards
• Other duties may be assigned

 

Secondary or peripheral job functions: 

 

• Must be able to travel by air and car, and work occasional weekends.
• Requires excellent written and interpersonal communication skills.
• This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
• Uses professional concepts in accordance with company objectives to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
• Coordinates and supports team activities using creative thinking and organizational skills.
• Works well with intermittent supervision.

 

Supervisory Responsibilities: N/A

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

•  BS in Mechanical Engineering or equivalent required.
• Master’s degree in Mechanical Engineering or Biomechanical Engineering preferred.
• General CAD experience. CATIA V5 preferred.
• 5 years industrial experience preferred.

 

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. 

 

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 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 20 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. 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 20 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.

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.

Equal Opportunity Employer Veterans/Disabled