Senior Engineering Specialist

Company: B. Braun Medical
Location: Irvine
Posted on: May 15, 2022

Job Description:

B. Braun Medical, Inc.Senior Engineering SpecialistUS-CA-IrvineJob ID: 2021-19474Type: Regular Full-Time# of Openings: 1Category: EngineeringIrvine FacilityOverviewAbout B. Braun B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap - and CAPS -. Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise - philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit .ResponsibilitiesPosition Summary: Responsible for functioning as an individual contributor and subject matter expert for plastics engineering. Provide expertise for maintaining cost and schedule requirements to meet business objectives. Demonstrate expertise within the plastics environment while supporting capital projects and while interacting with variety of functional groups that are directly involved with corporate functions, capital project life cycles and site operations. Responsibilities: Essential Duties

• Analyze potential root causes in case of product failures or production process issues through strong plastics engineering background.
• Lead technical discussions with vendors, laboratories and other external partners to address and understand plastics material or processing specific issues.
• Partner with global cross-functional team members, equipment design vendors, and other internal and external stakeholders as necessary to drive mandatory changes for sustaining products.
• Manage project team resources to achieve the agreed upon goals of the project, including the project schedule and budget, as well as the quality (e.g., scope and performance). Collaborate with the according stakeholders to ensure the seamless phase-in of product material, design or production process changes. Ensure the effective use of human, physical financial resources in order to achieve company objectives. Evaluate team member performance.
• Performs troubleshooting and modifications to the automated equipment adhering to Pharmaceutical and Medical Devices GMP change control standards and policies.
• Creates and modifies system specifications and standard operating procedures for the systems supported.
• Trains users and peers on systems.
• Supports software life cycle efforts.
• Contributes to development of continuous improvement to systems.
• Documentation, testing, commissioning and validation support following GDP.
• Provides project implementation support.
• Performs administrative, upgrades and maintenance tasks for control systems.
• Supervises consultants and contractors.
• Ability to manage medium complex projects without assistance.
• Recommends design improvements.
• Analyze potential root causes in case of product failures or production process issues through strong plastics engineering background.
• Lead technical discussions with vendors, laboratories and other external partners to address and understand plastics material or processing specific issues.
• Partner with global cross-functional team members, equipment design vendors, and other internal and external stakeholders as necessary to drive mandatory changes for sustaining products.
• Manage project team resources to achieve the agreed upon goals of the project, including the project schedule and budget, as well as the quality (e.g., scope and performance). Collaborate with the according stakeholders to ensure the seamless phase-in of product material, design or production process changes. Ensure the effective use of human, physical financial resources in order to achieve company objectives. Evaluate team member performance.
• Will or may be required to support floor activities nights and or weekends when required, rare/not often, but will be required when needed. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. Expertise: Knowledge & Skills
  • Requires advanced knowledge in plastics material engineering and processing. Influences the development and drives the implementation of changes. Determines the best course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, assigning and checking the work of lower level employees. Referring only complex problems and issues.
  • Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
  • Judgement is required in resolving complex problems based on experience.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
  • Requires advanced knowledge in plastics material engineering and processing. Influences the development and drives the implementation of changes. Determines the best course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, assigning and checking the work of lower level employees. Referring only complex problems and issues. Preferred Requirements:
    • Master Degree in Plastics or related field.
    • GMP or cGMP experience highly desirable.
    • CAPA's Deviation's Quality experience highly desirable.
    • High Volume Manufacturing experience highly desirable.
    • Black Belt or DMAIC process expertise a plus. QualificationsExpertise: Qualifications -Education/Experience/Training/Etc Required:
      • Bachelor's degree required.
      • 10-12 years related experience required.
      • Regular and predictable attendance
      • Occasional business travel required, Valid driver's license and passport 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. Additional Information 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:While performing the duties of this job, the employee is expected to:
        • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
          • Occasionally:Reaching upward and downward, Push/pull
          • Frequently:Stand, Sit
          • Constantly:N/AActivities:
            • Occasionally:Handling, Push/pull, Reaching upward and downward
            • Frequently:Sitting , Standing, Talking - ordinary, loud/quick, Walking
            • Constantly:N/AEnvironmental Conditions:
              • Occasionally:N/A
              • Frequently:Proximity to moving parts
              • Constantly:N/AWork 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.
                • Noise Intensity:Moderate
                • Occasionally:N/A
                • Frequently:Office environment, Production/manufacturing environment
                • Constantly:N/A What We OfferB. 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.NoticesEqual Opportunity Employer Veterans/DisabledAll 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.PI177357114

Keywords: B. Braun Medical, Irvine , Senior Engineering Specialist, Engineering , Irvine, California