B. Braun

Sr. Quality Engineer-Design Assurance

US-PA-Allentown
Requisition ID
2018-11574
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8am to 5pm
Site
Carrollton, TX

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:

 

Drive the Quality function on product development to support our Allentown, PA, R&D Active Device organization for new products, design modifications, and OEM customers. Apply the regulatory knowledge to device development projects to ensure translation of the requirements into product requirements and ensuring compliance to relevant standards with particular focus on risk management and design verification.

 

Responsibilities: Essential Duties

  • Provide an active role in Design Reviews to assess for quality and compliance
  • Support the creation of R&D Quality Plans and Validation Plans to document strategy and rationale for new and redesigned products.
  • Responsible for leading and documenting product risk management and analysis activities according to ISO14971 (including creation of Risk Management Plans, DFMEAs, FMECAs, Fault Tree Analysis and Risk Management Reports)
  • Support the creation of Design History Files/ Technical Files
  • Develop quality specifications for new products, processes, equipment, and technology.
  • Input on a variety of technical projects of moderate to complex scope. Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams.
  • Detects assignable causes of variation and implements means to reduce or control effects of variation on process or product output.
  • Defines implements and monitors metrics for key indicators. Prepare and present trend reports to management, as applicable.
  • Develop statistically valid sampling plans for various DoE, engineering studies, validations and quality inspections.
  • Provide quality and compliance direction, coaching and mentoring for company personnel.
  • Provides support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.  Proactively investigates, identifies and implements improved efficient and compliant Quality standard work. 
  • Ensure personal training in accordance with training plan.
  • Performs other related duties as required by management.

Expertise: Knowledge & Skills

  • Statistical sampling and quality control methods
  • Hypothesis testing
  • Design of experiments
  • CGMP’s, QSR’s, ISO, CMDR, and MDD
  • Risk Management and Hazard Analysis techniques
  • Data analysis
  • Excellent written and verbal communication, presentation and interpersonal skills
  • Ability to effectively manage multiple priorities and projects

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc


Required:

  • S. in Scientific or Engineering discipline
  • 8+ years Design Assurance experience
  • 5+ years of Quality experience in the medical device industry
  • 5+ years of personnel supervision
  • Strong understanding of quality policies, FDA Regulations and ISO Standards for medical device operations.
  • Strong knowledge of risk management with regards to medical products in accordance to ISO14971
  • Strong knowledge in product/test method/process validations, and design controls.
  • Strong knowledge in statistical process control and ability to apply advanced statistical techniques.
  • Demonstrated use of Quality tools, principles and methodologies including lean and six sigma principles.
  • Must be able to successfully work with all functional departments and all phases of company manufacturing and quality operations

Desired:

  • Advanced degree (M.S. or related Engineering discipline )
  • Certified Quality Engineer
  • Six Sigma Black Belt

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 30 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:

  • Occasional travel may be required.

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 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 bend, twist, stand and walk.  The employee must occasionally lift and/or move up to 30 pounds.
  • 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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