Sr. Staff R&D Engineer

Becton Dickinson Medical DevicesSandy, UT
Onsite

About The Position

The R&D team is seeking an exceptionally talented and passionate individual to help us identify and implement innovative solutions to address current and future health care needs in the Vascular Access markets. Within BD Medication Delivery Solutions (MDS) Research & Development, the associate in this position will be part of the Salt Lake City R&D team. Our R&D Engineers are responsible for developing and implementing new product designs, product improvements, and critical component changes for disposable and durable medical devices. The preferred candidate will have strong technical design skills, excellent written and oral skills, and leadership abilities. This candidate should possess a strong capability to interpret and ensure compliance with all local, state, federal and BD safety regulations, quality policies, best practices, and procedures through appropriate communication. This position is responsible for technical leadership and domain expertise in the area of pediatric and neonatal catheter development. This position is of a technical rather than managerial nature. Individuals in this position will typically lead a technical group and may manage major projects in more than one technical area. In addition, this position may provide technical expertise to other groups or projects.

Requirements

  • A bachelor’s degree in STEM (Science, Technology, Engineering, Math), and ten (10) years of engineering experience within a regulated industry, including at least two (2) years of experience in the medical device industry, Or: Or a master’s degree in STEM and eight (8) years of engineering experience within a regulated industry, including at least two (2) years of experience in the medical device industry.
  • Excellent analytical skills & discipline; able to conduct thorough analysis of concepts that have high uncertainty.
  • Excellent critical thinking skills; able to constructively challenge ideas and invite critical feedback.
  • Demonstrated familiarity with FDA, ISO, and Good Manufacturing Practice guidelines and regulatory compliance.
  • Strong knowledge of scientific, engineering, and technical principles.
  • Advanced engineering skills/specialized technical expertise: Molding/Extrusion, Design/mechanics/FEA, Statistics/Design of Experiments, Biocompatibility/coatings/materials, Clinical trials and animal testing.
  • Proven ability to foster a collaborative team environment.
  • Excellent written and oral communications skills
  • Ability to concurrently handle various projects and coordinate cross-functional teams' efforts.
  • Ability to work with in-house and outside support groups.
  • Ability to independently work with outside medical and technical professionals.
  • Strong skills in communicating with all levels of technical and operating management.
  • Strong ability to analyze and use technical data and resources.
  • Oral and written comprehension; Inductive and deductive reasoning.
  • Broad business and technical knowledge.
  • Influences others across organization.
  • Understanding of disciplined product development processes and quality requirements.
  • Understanding and ability to design for high volume manufacturing and/or durable electro/mechanical medical devices.
  • Strong fit with BD values.

Nice To Haves

  • Experience in the medical device industry strongly preferred.
  • Patent/industry awards.
  • National Committee/Association Leadership.
  • Able to draw upon technical breadth to evaluate concepts outside area(s) of personal expertise.
  • Strong interpersonal and influencing skills.
  • Excellent technical judgment.
  • Effective communication skills.
  • Demonstrated accountability for successful completion of designated tasks.
  • Team-oriented.
  • Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.
  • Knowledge of regulatory and quality requirements (21CFR820.30).
  • Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.
  • Experience with clinical studies, human physiology, and simulated product use studies.
  • Experience with contact and non-contact metrology.
  • Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
  • Experience with manufacturing process validation including strategy development, First Article Inspection, and Factory Acceptance Testing.

Responsibilities

  • Leads effort to determine new product development efforts and priorities.
  • Consultant/Division expert; Division Technical expert.
  • Provides technical leadership and domain expertise to cross-functional project teams aimed at the development of medical devices.
  • Works closely with other functions (i.e., Marketing, Operations, Quality, Engineering R&D) to troubleshoot, characterize and resolve needs in existing and adjacent devices.
  • Develops Innovative ideas for the organization.
  • Participates and leads cross-functional teams.
  • Provides technical support on components, material methods, systems, and equipment.
  • Critical Decision Maker in areas of engineering and business needs.
  • Prepares procedures, author technical reports, publishes research papers, and makes recommendations based on their research findings.
  • Engages in collaborative efforts with academics, hospitals, and other organizations.
  • May have responsibility for managing third-party relationships.
  • Develops and/or directs experimentation.
  • Effective communication skills to be able to translate technology and science into the business and position this to drive strategic decisions for the future (including strong presentation skills before large audiences).
  • Has experience and successful track record of understanding clinical needs and translating that information into successful products.
  • Responsible for concept generation, design, development and evaluation of new products, materials, and technologies.
  • Mentors and trains less experienced colleagues in best practices for product development, technology development, clinical assessment, manufacturing, and process development.
  • Manages project planning, budgeting, scheduling, and tracking.
  • Plans and coordinates engineering test builds.

Benefits

  • BD values: We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture.
  • Culture where face-to-face collaboration supports your learning, your progress, and your success.
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