B. Braun

Sr Product Development Coord

Job Locations US-CA-Irvine
Requisition ID
2021-19065
Company
B. Braun Medical Inc
# of Openings
1
Category
Other
Position Type
Regular Full-Time
Shift
8:00am- 5:00pm
Site
Irvine, CA

Overview

With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

 

U.S. Facilities and Operations:

 

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities

Position Summary:

Responsible for coordination of activities and administrative duties to support the Pharmaceutical Product Development Teams and the R&D Physical and Chemistry Laboratories.   

 

Responsibilities: Essential Duties

  • Assist Engineers and Scientists with day-to-day activities required to successfully complete project tasks.  Follow up with other departments and external organizations to ensure that requests are carried out and information is coordinated.
  • Assist with the initiation, routing, completion and documentation of the tasks associated with Change Control, Phase Gate, Design Control and related work-flows.  Track project deliverable to ensure they follow GDP through the various Product Realization processes.
  • Responsible for tracking and compiling R&D activity reports by aggregating data from multiple individuals; including department scorecards, monthly project reports, time reporting, and updating project status in PDWare database.
  • Responsible for routing project capital and expense requests and tracking the approvals of purchase orders.  Reconcile department and project expenditures and cross-charges.  Assist with financial summaries as directed.
  • Route electronic documents for approvals through the B.DoCS document management system.  Assist in creating and updating information such as bills of materials (BOM) and standard operating procedures.
  • Enter hand-generated documentation into electronic format such as Excel and MiniTab (i.e. 10-key data entry).  Conduct basic data analysis to help determine data integrity (i.e. evaluate standard deviations).  Review raw data for completeness and thoroughness.
  • Assist with the creation of PowerPoint presentations.  Develop, type, copy, fax and distribute routine reports, manuals, agendas, and correspondences for Project teams.
  • Maintain the training curricula for the department and coordinate on-boarding of new employees.
  • Track, order and maintain inventory levels of raw materials, chemicals and supplies for the engineering and chemistry labs, and supplies for the office spaces.
  • Maintain general office and laboratory work environments creating facility maintenance work orders, coordinating the servicing of instruments and equipment, creating IT requests, etc.
  • Coordinate engineering lots/builds and product sample shipments for manufacturing, sterilization and testing.
  • Other duties may be assigned

Responsibilities: Other Duties

  • The duties performed are generally of a confidential nature and require a thorough knowledge of practices and procedures of the function, company products, policies and programs.
  • Must comply with applicable ISO, ASTM, USP, and FDA regulations as stated in the Quality Manual.
  • Must embody the Company’s Vision, Mission, and Values.

 

 

Expertise: Knowledge & Skills

  • Language Skill: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries from vendors, staff, or members of the business community.
  • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to apply mathematical operations such as formulas to such tasks as month-end financial calculations, analysis of variance.
  • 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.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • BS/BA degree is preferred, or commensurate industry experience supporting technical teams.
  • 10+ years of relevant experience preferably in pharmaceutical or medical device industry.
  • Completion of high school, or a secretarial training program from an accredited school with business or accounting fundamentals.
  • Requires PowerPoint, Word, Excel/MiniTab proficiency (10-key and typing).
  • Requires excellent oral and written communications skills.
  • Requires procedural skills in reading, writing and arithmetic.
  • Requires computer knowledge of manufacturing, scheduling and time-tracking systems.
  • Understanding of research documentation practices and product manufacturing principles.
  • Must be familiar with Document Control and Quality Assurance systems (ISO, GMP, GLP)
  • Understanding of product development, sterilization and testing workflows and procedures.
  • SAP and Microsoft literate.
  • Self-motivated and able to collaborate in an environment with minimal direct supervision.

 

 

Desired:

  • N/A 

 

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.

 

 

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

 

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

Other

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.

 

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. The noise level in the work environment is usually moderate.

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