R&D Senior Engineer (1 of 2)


The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a R&D Senior Engineer aligned to Acclarent, Inc located in Irvine, CA.

The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.


Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat. Learn more about Acclarent at www.acclarent.com


Acclarent, Inc. is seeking a R&D Senior Engineer who is hands-on and will execute specific & general assignments/projects that provide innovative, functional, cost effective & validated product designs in a team based environment. The ideal candidate has a strong mechanical engineering background.


ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the responsibilities of the position include:

  • Participate in development projects core teams as the R&D representative and technical lead
  • Ability and discipline to adhere to schedules and tasks based on instructions/guidance from engineering leadership.
  • Ability to build prototypes, including device assembly under a microscope.
  • Ability to maintain & operate equipment, such as 3D printers, laser welder, and CNC machine.
  • Ability to derive product requirements from customer needs, apply critical thinking and lead the process of identifying the few critical requirements.
  • Assist in developing product concepts, specifications, drawings, & work with quality and other team members to develop design verification/validation protocols.
  • Work with an engineering team to establish design specifications based on product requirements and risk analysis.
  • Build simulations and models of product functions and expected performance, and lead feasibility studies
  • Provide deliverables (drawings, specifications, protocols and reports) to technical design reviews
  • Perform stackup analysis for mechanical tolerance and error budget for critical measurements.
  • Occasionally interface with customers as an R&D representative.
  • Plan and conduct system and sub-system verifications and validations
  • Participate in in-vitro and in-vivo studies including animal and human evaluations as part of product development.
  • Act as liaison between external vendors and core team
  • Develop Test Methods and conduct hands-on bench testing on Products to analyze Performance, and keep laboratory notebooks on all work.
  • Travel to customer sites, to gather VOC, perform testing and/or perform troubleshooting activities
  • Perform supportive tasks for the product development process, such as issue purchase orders, manage inventory of equipment, manage calibration of test equipment, and similar tasks.
  • Multi-task on multiple projects or multiple activities on one project.


Qualifications
  • A minimum of a Bachelor’s of Science Degree in Mechanical/Electromechanical Engineering and a minimum of two (4) years of related experience is required.
  • Experience in catheter design, development, testing or manufacturing is highly preferred.
  • Working knowledge in using test lab equipment and integration for testing purposes using them is preferred.
  • Demonstrated proficiency in solid modeling or similar CAD design is required.
  • Ability to use Solidworks is required.
  • Experience in product development processes and in documentation writing is preferred.
  • Experience with design control is preferred.
  • Experience with engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control preferred.
  • Experience in the medical device or the aero-space industries is a plus.
  • Must have excellent communication skills and the ability to express complicated technological ideas in layman terms
  • Self driven individual who is capable and excited to learn about new technologies
  • This position is located in Irvine CA and may require up to 20% travel internationally/domestically.
  • Weekend travel/work may be required.


Primary Location
United States-California-Irvine
Organization
Acclarent, Inc. (6206)
Job Function
R&D Engineering (R&D)
Requisition ID
2267180525