C. R. Bard, Inc.

Quality Reliability/Risk Engineer

Posted Date 2 weeks ago(3/6/2018 1:02 PM)
Industry / Category
Reliability Engineer
Job ID
Career Level
Bard Medical Division


C.R. Bard is looking for a talented and experienced Senior Reliability Engineer to support capital equipment development at our Bard Medical Division location in Louisville, CO.

Summary of Position with General Responsibilities

• The job performance requires technical abilities as well as an understanding of product design, development and reliability methodologies.

• This person leads design for reliability efforts in support of new product development.

• This individual interfaces with management to sustain and further develop the reliability program.

• This individual champions the reliability program throughout Bard by incorporating latest reliability engineering technology and methodology into the product development process and coaching engineering teams in the field of reliability.

• This position is with a Medical Device company, experience working in a regulated industry is needed; FDA and Regulatory requirements and Standards are preferred.

Essential Job Functions

  • This individual works with a cross functional project team under minimal, consultative direction to toward predetermined long-range, high-impact goals.
  • This individual plans, conducts, and directs reliability engineering research and development projects of major significance which are very difficult and complex in nature and require the expert application of advanced engineering knowledge from several different fields and resolves difficult root cause failure analysis to prevent future failures.
  • Be able to work independently applying comprehensive and diverse engineering principles and practices to broad assignments under the direction of Technical Management.
  • Review new product concepts; and in conjunction with a product development team, develop performance specification and project schedules.
  • This individual authors DFR plans, studies and reports in support of these efforts. This person conducts analysis of reliability problems and investigates to determine the reliability required for the particular situation considering the cost limitations for equipment up/down time, repair/replacement costs, weight, size, and availability of materials/equipment. This individual determines the cost advantages of alternatives for developing action plans to comply with internal/external customer demands for reliable processes/equipment to avoid failures. This individual acquires and analyzes data to gauge design strength relative to functional stress, identify high reliability risk components/features, and gauge component/product life
  • This individual will drive techniques such as component de-rating, physics of failure based root cause analysis, FMEAs, reliability hazard analysis, predictive and preventive maintenance, accelerated testing techniques, and application of statistical analysis techniques (e.g. Weibull, Weibayes, Chi-squared, DOE, multiple regression analysis, etc.)
  • This individual will develop laboratory tests, protocols and reports to assure conformance of prototype devices to performance specifications and meet applicable regulatory requirements.
  • Other techniques include circuit analysis, finite element analysis, warranty / Total Cost of Ownership modeling, issue tracking to closure such as FRACAS or DRBFM, and MTBF, MTTR.
  • This individual prepares diagrams, charts, drawings, calculations, and presentations. This individual translates relevant data/information into broadly understandable terms to convey risks and provide the means by which project trade off discussions and decisions may be made.
  • Closely follow established design control procedures and documentation practices.
  • Evaluate device performance through animal and/or human clinical investigation; and, as required, implement appropriate product changes to include revision of performance specifications.
  • Interface with vendors, consultants, and customers. Provide guidance on the development of supply agreements as required.
  • Communicate project status, through verbal and written reports and schedules, to management.

Basic Qualifications

• Technical depth, strong communication, prior leadership experience is preferred. Must be a strong communicator (verbal and written), self-motivated/proactive, able multi-task, have strong attention to detail, and superior documentation skills.

• Proven ability to interface with various levels of the organization.

• Understanding of manufacturing methods including plastic injection molding, metallic stamping/forming, and metallic machining.

 Requires solid understanding of:

o Industry regulations as it pertains to medical devices

o External Standards, Design controls, Quality controls, Manufacturing methods


 Requires track record of:

o In depth or creative approach to problem solving

o Contributes to development of new concepts

o Capable of prioritizing tasks and provide a timely schedule of completion.

o Capable of performing complex analysis independently

o Demonstrated proficiency in communicating best practices

o Protocol/report testing and writing

Education and/or Experience

  • A minimum of a Bachelor’s degree
  • Minimum of 5 years of engineering experience is required. Medical device industry experience is preferred.
  • Familiarity with any/all of the following greatly preferred: electrical noise, fluidics, material compatibilities Reliability engineering certification (e.g. ASQ Certified Reliability Engineer, SMRP Cert, Reliasoft Certified Reliability Professional, etc.) Six Sigma certification is preferred.).
  • Microsoft Word, Excel, PowerPoint, Access and Microsoft Project and statistical software packages.

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.
  • While performing the duties of this job, the employee is regularly required to sit, talk, and hear.  The employee is frequently required to use hands to handle and feel.  The employee must be able to lift or move boxes of product/raw materials.  Specific vision abilities required by this job.

Work Environment


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