Prinicpal Quality Engineer I

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. #LI-SF1

Summary of Position with General Responsibilities:

• This position is responsible for manufacturing process improvements within the BPV portfolio and will provide engineering support to the plastic molding processes at BPV’s suppliers. Individuals in this position will typically lead a technical group and many manage major projects in more than one technical area.

• 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 injection molding processes and validations with BPV’s suppliers using scientific injection molding principles.

• Monitor existing molding issues at BPV’s suppliers with execution of continuous improvement opportunities.
• Mold subject matter expert contact for BPV’s pre-market team, suppliers and contractors during development, build, and qualification of new and existing molds.
• 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 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.
• 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.
• Leads failure investigation teams.
• 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 such as injection molding.
• Supports translation & implementation of design inputs into manufacturing control plans
• Supports Product Development Teams in technical areas.

Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

Basic Qualifications:

• 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)

Additional Desirable Qualifications Skills and Knowledge:

• Knowledge and application of molding processes to support Quality improvements.
• Ability to generate and present engineering decisions/proposals.
• Strong interpersonal skills.
• Advanced engineering skills/specialized technical expertise
  • Molding/Extrusion.
  • Design/mechanics/FEA.
  • Statistics/DOE.
  • Biocompatibility/coatings/materials.
• 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 .

Education and/or Experience:

• B.S. in Mechanical Engineering Technology / Mechanical Engineering
• M.S in Engineering or Technology preferred

• 10 years or more in medical device manufacturing
• 10 years or more years in plastic injection molding including process, component design and material selection. Experience should include secondary processes (i.e. – Pad printing, laser marking/etching, sonic welding, etc.)

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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C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.

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