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.
The Sr. Engineering Specialist performs dual responsibilities of Technical Resources and Project Manager. As a Technical Resources, provides an exceptional level of technical know-how and expertise within a specialty field(s) within the Engineering organization. As a Project Manager, lead the preparation and execution of project plans for multi-million dollar New Product Implementation projects, Capital Improvement projects, and assists with the development and continuous improvement of standard work for project management.
The Sr. Specialist manages cross-functional team resources throughout the project life cycle and is accountable for meeting the agreed upon project scot, schedule, budget and quality. Collaborate with internal resource managers and external partners to properly staff their project and manage project risk to ultimately provide an end result that performs at the expected quality level. In addition, the Sr. Specialist will support the development and improvement of project management systems, including the phase/gate process for new product innovation and development, using industry best practices (e.g., Lean Product Development). The PM will have an understanding of Manfuacturing Controls (CMC) requirements (e.g., cGMP, GCP, USP), and skills and experience in the use of world class project management principles (e.g.,PMI PMBOK).
Responsibilities: Essential Duties
Partner with global cross-functional team members, equipment design vendors, architectural and engineering firms, and other internal and external stakeholders as necessary to prepare business cases and justify capital for proposed new projects.
Lead or provide tactical guidance for the planning and execution of new product projects from the Conceptual phase through Closure. This includes responsibilities for facilities, equipment, supply chain, and other outside services, staffing, operating procedures, policies and standards.
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 Project Sponsors, existing Business Units, Marketing, Finance, Operations, Quality, Facilities, Maintenance, Regulatory Affairs, and other stakeholders to ensure the seamless phase-in of new products.
Ensure the effective use of human, physical and financial resources in order to achieve company objectives.
Evaluate team member performance.
Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, product cost goals, and other key performance indicators.
Monitor and confirm organizational adherence to policies, procedures, regulations and standard work.
Drive and support implementation of major cost savings and continuous improvement projects (e.g. Kaizen events).
Communicate effectively to all levels of the organization using all forms of communication.
Drives effective and timely problem solving through the use of team resources and Lean/Quality tools (e.g., DMAIC).
Responsible for developing, monitoring and achieving any assigned budgetary goals.
Creates and delivers presentations to all levels of the organization regarding project timing, cost, risks and quality (scope and performance).
Conducts periodic review with the project team and with management to ensure that phase/gate transition criteria are met in the most efficient manner.
Cultivates a positive team spirit and a healthy team dynamic. Ensures that the team develops and maintains a common mission and vision of success throughout the project life cycle.
Draft required project and validation documentation including equipment specifications, operating procedures and protocols (FAT, SAT, IQ, OQ).
Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.
Expertise: Knowledge & Skills
Demonstrated Project Management knowledge of tools, techniques, culture, software applications, such as Microsoft Project.
Quality Systems, GMP, FDA
Product development and sustaining engineering knowledge
Ability to communicate (face to face, team meetings, provide presentations, and train employees) with every level of the company, as well as with customers and suppliers.
Good team building skills and ability to lead cross functional / international teams.
Demonstrated success in leading project teams and managing projects from initiation through completion.
Knowledge of project management software such as MS Project.
Expertise: Qualifications - Experience/Training/Education/Etc
BA/BS degree in Engineering (Industrial, Mechanical, Process, Manufacturing, Electrical) or Technology, plus a minimum of 8-10 years related experience in forms of Project Management.
Must have experience in either the Pharmaceutical or Medical Device industry.
Domestic and International travel.
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:
Other duties as assigned.
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.
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.
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.