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BD (Becton, Dickinson and Company) Sr. R&D Engineer in Tempe, Arizona

Job Description SummarySupport Integration

Job Description

This is a high-level research and development engineering position. 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 / quality / manufacturing experience in new product and process development. Responsible for both the technical aspects of product design and development as well as the translation of marketing requirements into product specifications. Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

  • Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.

  • Maintains a professional working relationship with internal & external customer and support staff.

  • Participates and leads cross-functional teams.

  • Provides technical support on components, material methods, systems and equipment.

  • Develops physical and functional test requirements to assure specifications and regulations are met.

  • Writes and approves protocols, reports and data.

  • Manages testing outlined in protocols and test methods.

  • Manages/develops validation studies on equipment & processes.

  • Conduct complaints investigations.

  • Understands and follows company procedures and regulatory requirements.

  • Participates in and provides input to training on department & division procedures, and policies

  • Manages project planning, budgeting, scheduling and tracking.

  • Plans and coordinates engineering test builds.

  • Analyzes problems in design, process and test development. Recommend/implement solutions.

  • Prepares and presents oral and written project updates and technical discussions.

  • Develops and implements procedures/policy.

  • Experience as the lead R&D engineer on a medical device product development program

  • Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development

  • Design capability with small plastic and metal parts

  • Demonstrated proficiency with Geometric Dimensioning and Tolerancing (GD & T)

  • 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, food/beverage).

  • Clinical trial 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 with a high amount of change

  • Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Taguchi Design of Experiments)

  • Familiarity with Solid Works and/or FEA software

  • Ability to make and present engineering decisions.

Bachelor’s degree in science or engineering plus four to eight years, (Master’s degree plus two to six years, or Ph.D. degree with zero to four years) of engineering experience within the medical device or equivalent industry.

Primary Work LocationUSA AZ - Tempe BPV Building 3

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.