C. R. Bard, Inc.

Principal Quality Engineer

3 weeks ago
Industry / Category
Medical Device/ Quality
Job ID
2017-10831
Career Level
experienced
Division
Tempe/BPV
Relocation
Yes
US-AZ-Tempe

Overview

Bard Peripheral Vascular is located Tempe, AZ – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. #LI-JC1

Summary of Position with General Responsibilities

  • This position is responsible for manufacturing process improvements within the BPV portfolio and will provide technical support to the manufacturing processes at BPV’s internal and external suppliers.  Individuals in this position will typically lead a technical group and many manage major projects in more than one technical area.
  • This position provides support to ensure (thru training, measurement and monitoring) that the Quality Engineering population has appropriate level of skill set competency to execute their required deliverables.
  • The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Essential Job Functions

    • Develop/support process improvement initiatives for BPV products at Bard Operating site(s) or contract manufacturer facilities.
    • Support cost savings projects including scrap reduction (Quality improvements), uptime improvement and process simplification to reduce risk.
    • Develop/Support manufacturing processes and validations with BPV’s internal and external suppliers.
    • Monitor manufacturing issues at BPV’s suppliers with execution of continuous improvement opportunities.
    • Conduct root cause analysis of product quality issues and equipment failures. Develop robust solutions to prevent reoccurrence.
    • Document changes to processes and equipment using change management system.
    • Write and support the execution of validation protocols (IQ/OQ/PQ) that comply with FDA/ISO regulations and CR Bard Policies.
    • Potential Task Assignments within the scope of this position:
    • Maintains a professional working relationship with internal & external customers.
    • Participates and leads cross-functional teams.
    • Leads failure/ root cause investigations of major complexity internally and externally
    • Effectively negotiates the implementation of corrective & preventive measures.
    • Provides technical support on components, material methods, systems, equipment & process optimization.
    • Prepares and presents oral and written project updates and technical discussions.
    • Writes and approves protocols, reports and data.
    • Manages testing outlined in protocols and test methods
    • Manages/develops validation studies on equipment & processes.
    • Develops and presents training in area of expertise.
    • Plans and coordinates engineering test builds.
    • Analyzes problems in design, process and test development. Recommend/implement cost effective solutions.
    • Supports component qualifications including design verification and process validation.
    • Optimizes processes and implements procedures regarding manufacturing processes.
    • Supports translation & implementation of design inputs into manufacturing control plans
    • Supports Product Development Teams in technical areas.
    • Apply Quality Engineering/Scientific tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

Basic Qualifications

Knowledge & Skills:

  • Knowledge and application of manufacturing processes to support Quality improvements.
  • Ability to generate and present engineering/scientific decisions/proposals.
  • Strong interpersonal skills.
  • Advanced engineering/scientific skills/specialized technical expertise
    • Validations/FMEAs/Control Plans
    • Statistics/DOE
    • Biocompatibility/coatings/materials/mechanics.
  • Advanced problem solving ability/root cause analysis.
  • Ability to create, review and coordinate test protocols and reports.
  • Excellent oral and written presentation skills.
  • Ability to lead and produce results in a cross-functional team environment.
  • Comprehensive understanding of regulatory environment.

Supervisor/Management Responsibilities:

  • This position may be assigned Quality Engineers to supervise

Fiscal/Budgetary Responsibilities:

  • This position has no budgetary responsibility other than to provide input when required

Customer and Key Contacts:  

  • BPV R&D, RA, Quality (internal)
  • BPV Third Party manufacturing sites
  • BPV Bard manufacturing sites
  • BPV Bard manufacturing sites – Third party manufacturers and or BPV suppliers

Additional Desirable Qualifications Skills and Knowledge

  • Thorough knowledge of manufacturing processes such as:
    • Injection Molding Processes (i.e.- Scientific/Decoupled Molding) and material selection
    • Polymer Extrusion (Thermoplastics /Thermoset plastics)
    • Sonic Welding including component design, material selection
    • Laser Welding, Marking and Etching (Metals/Polymers)
  • Understands and has the ability to identify and drive patient, compliance and business risk mitigation activities.
  • Working knowledge of quality systems
  • Ability to analyze data and apply statistics to make decisions.

Education and/or Experience

  • B.S. in Engineering  or Technical Science
  • M.S in Engineering or Technical Science preferred
  • 8 years or more in medical device manufacturing

Physical Demands

  • While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

  • Candidate must be able to work in a team-oriented, fast-paced environment.
  • Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
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