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Senior R&D Engineer- HDS

Apply Now Job ID R-331825 Date posted 03/05/2019

Job Description Summary

Job Description

Within BD Medication Delivery Solutions (MDS) Research & Development, the successful candidate will have a unique opportunity to be part of a dynamic product platform team. The Design and Development R&D team supporting the business’s Hazardous Drug Safety (HDS) platform is seeking a highly talented and passionate individual to help the team identify innovative solutions to address current and future health care needs and to better address our current customer segments.  The associate will contribute to the product design, development and commercialization of medical device products that improve drug delivery through adherence to established design control processes and good engineering and documentation practices.

Requirements:

This important position requires the following minimum qualifications:

  • Bachelor’s degree in a technical field required (Mechanical or Biomedical Engineering or closely related field). MS or PhD preferred.
  • Minimum 5 years of experience as a product design / development engineer in the medical device, pharmaceutical or other regulated industry (experience with FDA class II or III high volume, plastic, disposable medical devices preferred)
  • Successful track record of leading large, complex product development efforts that consist of one or more projects under development for a specific platform or business segment. This person will lead all R&D aspects of development on their program, which may cover from the start of the Concept or Definition Phase through successful completion of the Launch Phase and Program closeout utilizing a structured, phase-gated, product development process

Additional and preferred qualifications:

  • Proficiency in SolidWorks or other equivalent 3-D CAD modeling software and Computational Fluid Dynamics, and Finite Element Analysis
  • Familiarity with drawing practices/standards and dimensioning techniques (GD&T)
  • Ability to perform axial and radial tolerance stack-up analysis on complex parts and assemblies
  • Applies mechanical design and analysis principles in the development of product concepts, detailed designs & design changes and failure analyses
  • Can develop product specifications, project schedules/timelines and work package estimates
  • Test existing and new products to be able to identify key factors in complex tradeoffs; asses them effectively to identify and communicate optimum solutions relative to the next best alternative
  • Works with self-direction, takes initiative, exercises sound judgment, discretion, and capable of complex decision making in a dynamic work environment
  • Experience with design optimization for high-volume manufacturing methods such as injection molding, ultrasonic welding and automated assembly and packaging processes
  • Experience choosing and designing with various thermoplastics and synthetic rubbers
  • Experience with all phases of the Design Control process
  • Strong decision-making capability, even with limited or ambiguous information with the ability to absorb information and solve complex problems quickly
  • Experience with Design for Six Sigma mythologies including use of use of 1st principles, design of experiments, and transfer functions to assess technical performance and impact of variation especially as it relates to tightly controlled, high-volume manufacturing processes
  • Familiarity with manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ
  • Familiarity with translating customer needs into technically and commercially vetted concepts to be rolled into development, preferably in clinical setting
  • Experience with CAPA process from investigation phase through effectiveness check of corrective action
  • Basic understanding of the requirements management process, with demonstrated experience in design verification strategy and implementation
  • Good understanding of medical device product development risk management methodologies
  • Proficiency with statistical techniques including Minitab
  • Proficiency in Microsoft Project or equivalent project planning software
  • Basic understanding of intellectual property (IP) considerations, including how to disclose, secure and establish intellectual property on new ideas/concepts
  • Demonstrated ability to clearly and effectively communicate (verbal & written) concepts

Job Responsibilities

  • Perform technical role on project to execute deliverables for product development or improve the existing products from concept to product commercialization
  • Position may include developing and mentoring other less experienced engineers and technicians.
  • Develop, modify, implement and support of hazardous drugs safety products through adherence to established design control processes and good engineering practices. Solve technical problems using engineering and statistical techniques. Interfaces with customers and suppliers on high-volume disposable medical device design.
  • Makes design changes to existing products, ensuring compatibility through appropriate testing. Provides engineering and technical support to production with respect to product specifications and requirements. Guides the successful completion of major programs or projects.
  • Concept Design: Develop concepts through various stages of prototyping to final design by applying sound and good engineering principles including product requirements, concept design and selection, prototyping, testing, etc.
  • Design for Manufacturability: Design and develop high-precision plastic injection molded components for high-volume production. Apply DFSS, DFA, DFX and other fundamental engineering practices.  Design complex components and assemblies capable of achieving overall device requirements. Perform design verification and transfer to production.
  • Customer: Work directly with Clinicians to review product performance.  Gain feedback and implement changes based on clinician feedback. There will opportunities to be spend time with the customer and the patient. Ability to understand customer requirements and translate those requirements into product designs is required for effective performance in this position.
  • Team Work: Serve as a lead technical role on the project team.  The incumbent will work closely with fellow R&D engineers, Customers, Marketing, Sales and Manufacturing regarding New Product Development and/or Sustaining Engineering activities. The position requires a team-oriented individual with strong interpersonal skills.
  • Efficiency: Experienced in working on projects with tight timelines and budgets in highly matrix organization. Self-driven and always look for more efficient and effective ways of achieving results. 
  • Functional Excellence: Interested in contributing to the continued improvement of the way in which work gets done within the overall Design & Development organization, including Infusion Specialty Disposal (ISD) R&D organization that HDS R&D falls under.

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

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