Sr Product Development Coord at B. Braun Medical Inc.

Posted in Other 13 days ago.

Type: Full-Time
Location: Irvine, California





Job Description:


Sr Product Development Coord

US-CA-Irvine

Job ID: 2021-19065
Type: Regular Full-Time
# of Openings: 1
Category: Other
Irvine Facility

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.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI146983841

Salary: $34.00


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