C. R. Bard, Inc.

Senior R&D Engineer

2 months ago
Industry / Category
Medical Device/Engineering
Job ID
2017-10078
Career Level
experienced
Division
Tempe, AZ/ 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-SF1

Summary of Position with General Responsibilities

Requires a high-energy individual with excellent teamwork, partnering and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development/manufacturing experience in new product and process development. This position is responsible for being the technical lead on a new medical device platform that will involve both capital and disposable medical devices. This position will require previous capital experience. This is a great opportunity for a technically savvy engineer to get in on the ground floor and develop a new progressive platform technology.

Essential Job Functions

  • Working knowledge of mechanical design tools, e.g. Solidworks
  • Programming Language fluency; C/C++, Ladder Logic, G-Code and VB a plus.
  • Experience with PLCs, HMI’s, PID controllers, Sensors, Transducers, Linear Actuators, Servo and Stepper Motors
  • Ability to design and troubleshoot complex electro-mechanical equipment
  • Ability to design electrical schematics, Serial communications via RS232 and RS485 protocols, Working knowledge of digital and analog I/O , Experience with industrial process control using 4–20 mA current loops.
  • Ability to make and present engineering decisions.
  • Strong interpersonal skills.
  • Previous experience with the following:
    • Capital equipment design and system integration
    • Hardware and/or software
    • Electromechanical devices
    • Extrusion and injection molding
    • Ultrasound (a plus)
    • Electrophysiology (a plus)
  • Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
  • Design capability with small plastic and metal parts. Previous hands-on design experience.
  • Working knowledge of various materials typically used in medical devices.
  • Significant experience in product verification and validation testing, medical device new product development and rapid prototyping.
  • Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, etc.).
  • Strong problem solving ability
  • Clinical and/or animal trial experience
  • Proficient in technical writing of protocols and reports.
  • Proven capability in writing clear and detailed testing and product assembly procedures.
  • Impeccable documentation skills and adherence to design control procedures and GLP
  • Demonstrated experience in application of lean manufacturing principles.
  • Comfortable in a dynamic working environment
  • Demonstrated ability in using statistical experimental design and analysis technique

Basic Qualifications

  • Participates as a team member on product design teams and performs related design functions; including product design, analysis, support equipment design and trouble shooting, and technical writing.  
  • Analyzes problems in design, process and test development.       Recommend/implement solutions.
  • Prepares and presents oral and written project updates and technical discussions.
  • Provides technical support/guidance on components, materials, methods, systems and equipment.
  • Develops physical and functional test requirements to ensure specifications are met.
  • Writes and approves protocols and reports.
  • Manages testing outlined in protocols and test methods.
  • Manages/develops validation studies on equipment and processes.
  • Plans and coordinates engineering test builds.
  • Maintains a professional working relationship with internal and external customers and support staff.
  • Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
  • Conducts complaint investigations.
  • Understands and follows company procedures and regulatory requirements.
  • Participates in and provides input to training on department and division procedures and policies.
  • Develops and implements procedures/policy.
  • Will be responsible to manage 1-2 R&D Technicians.
  • Will be responsible to obtain approval for any project spend.
  • Will work internally to support R&D and Operations Departments and externally with suppliers on equipment needs.

Education and/or Experience

  • Bachelors degree in engineering required. Advanced degree (Master’s or PhD) preferred.
  • Minimum of 5 years experience within the medical device industry with a Bachelor’s degree or advanced degree (Master’s or PhD) plus 3 years of engineering experience within the medical device or equivalent industry.

 

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

  • While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
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