B. Braun

  • Manufacturing Project Engineer

    Job Locations US-CA-Irvine
    Requisition ID
    B. Braun Medical Inc
    # of Openings
    Position Type
    Regular Full-Time
    8:00am - 5:00pm
    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.


    Position Summary:

    The Manufacturing Project Engineer, together with the Manufacturing, Quality Engineering and QC Process Control teams will be accountable for the performance of their assigned operational area against key business objectives such as safety, quality, compliance, and production costs/output. The Manufacturing Engineer will drive peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated manufactured products.  Further, the Manufacturing Engineer will:


    Responsibilities: Essential Duties

    • Actively participate in, support and monitor effectiveness of Material Review Board actions to include product impact assessment, product correction, investigation, root cause analysis, identification and implementation of corrective and preventive actions as applicable. Monitor effectiveness of actions taken.
    • Build and sustain a problem solving culture through coaching, mentoring, facilitating and using data driven root cause analysis with tools such as Fishbone Diagram, 5 Whys, Contradiction Matrix and others as necessary.
    • Monitor business performance through the use of leading Key Performance Indicators and supporting data trending. Take action to investigate and correct as trends shift.   
    • Evaluate complaint samples received from customers to support effective investigation. Level of support required is based upon product, technical and functional expertise.
    • Coach and mentor peers to instill a quality mindset by strictly following procedures, reporting issues and escalating as necessary to ensure compliance.
    • Demonstrate and encourage a culture of quality by stopping processes when an issue is observed or reported with potential to impact safety, quality and/or compliance.
    • Monitor and trend financial data by respective functional area. Identify opportunities to improve manufacturing or business processes.  Implement actions that reduce waste, scrap and time, etc., resulting in lower cost of goods sold.
    • Create standard work and implement process improvement to reduce the incidence of product impacting discrepancies and/or minimize delays associated with discrepancy containment, investigation and immediate corrections.
    • Actively model, coach and engage employees to ensure safe conditions (ergonomics) and actions (behaviors) in all applicable functional work areas. Proactively correct identified hazards to prevent incidents and injury.
    • Drive and participate in red dot walks and/or risk assessments to identify and eliminate unsafe conditions and unsafe behaviors.
    • Ensure individual training requirements are completed on time. Review and revise curricula as job requirements change.  Identify ongoing job specific and/or technical training needs to sustain competencies.
    • Provide guidance for DN input
    • Work with manufacturing to ensure effective correction and corrective action are identified and completed.
    • Ensure root cause analysis is performed for assigned operational areas.
    • Support and provide input for quality trending related CAPA's
    • Actively participate in determining Product Impact Assessment and Product Correction Strategies (To be Immediately determined on the floor and in MRB meetings, as needed)
    • Review OOTIs prior to QA approval
    • Responsible for ownership and upkeep of pFMEAs (Process Failure Mode Effectiveness Analysis) for assigned operational areas
    • Identify and implement process related improvements
    • Participate in customer complaint investigation
    • Collaborate with Manufacturing, Quality and Maintenance to ensure effective corrective action(s) are identified, implemented and monitored.
    • Utilizing data and trends, outline continuous improvement opportunities in Pareto format to eliminate repeat and reoccurring discrepancies. Track effectiveness measures through completion.
    • Support EHS or incident investigations in accordance with internal and regulatory requirements.
    • Champions of culture of reliability; drives reliability centric methodology, programs, processes and mindset in the team to improve performance of the assets and people.
    • Monitors maintenance processes for compliance with the Company, FDA, OSHA, and GMP regulations.
    • Assist in coordinating plant shutdowns in his/her areas of responsibility to include preventative maintenance, major projects, and plant modifications.
    • Works with other groups on process, quality, and cost improvement projects as well as in the resolution of major issues.
    • Interfaces with outside vendors for equipment purchases and maintenance.
    • In conjunction with maintenance and operations, ensures that all assigned operational areas and equipment are maintained in good housekeeping condition.

    Expertise: Knowledge & Skills

    • Demonstrated expertise within an engineering specialty(s) area.
    • Understanding of statistics and its application in Engineering.
    • Knowledge of GMPs both basic and unique to the department’s specialty(s) area.
    • Software packages such as MS Office.
    • Understanding of quality by design.
    • Excellent understanding of manufacturing methods related to the department specialty(s) area.
    • Motivation and team building skills.
    • Ability to supervise all levels of personnel.
    • Budgeting and budget management.
    • Project prioritization.
    • Communication skills, both verbal and written, commensurable with dealing with senior level management.
    • Motivation and team building skills.
    • Ability to communicate clearly, both written and verbal within all levels of the organization.
    • Ability to work in a dynamic, high pace and a matrix environment to execute tactical tasks assigned through influence and deliver results with minimum supervision.
    • Ability to effectively influence/ collaborate with cross-functional, cross-cultural team to meet business objectives.
    • Ability to engage people with different opinions, thoughts and convictions on work-critical technical or business issues and to build alignment to move business forward.
    • Working knowledge in Budgeting, budget management, Project prioritization and business case development
    • Knowledge of GMPs both basic and unique to the department’s specialty(s) area.


    Expertise: Qualifications - Experience/Training/Education/Etc


    • BS in engineering discipline with minimum of 8 years of experience in engineering position with at least 5 years of demonstrated successful performance/experience in an applicable engineering position.


    • Experience in predictive maintenance technologies.
    • Previous experience in a similar function.
    • Experience in Pharma or Medical Device Manufacturing.
    • MS in Engineering or Science.

    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.


    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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