Staff Engineer
Location:
San Jose , California
Posted:
April 02, 2017
Reference:
6931170119-en-us

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Engineer aligned to Pulsar Vascular located in the Los Gatos, CA area.

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.

Codman Neuro is a global neurosurgery and neurovascular company that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Learn more about Codman Neuro at  www.codman.com for more information. Pulsar Vascular is a leading developer of breakthrough platform technology for the neurovascular treatment of complex aneurysms, including the PulseRider system, a minimally-invasive, self-expanding nitinol implant. 

Responsibilities
  • General manufacturing engineering support including ongoing production support to resolve issues and improve production through designing, evaluating, improving, qualifying and validating production line tools, processes, equipment, and fixtures.
  • As needed, participate with R&D teams to communicate manufacturing requirements, and assist in assuring new product manufacturability within established or newly developed capabilities.
  • Participate with QA, R&D, & Supply Chain to address component & process specifications & other materials supply issues
  • Work independently and with other resources to apply engineering skills to improve ongoing manufacturing and assist in the translation of new products for smooth & profitable production.
  • Assist in the design, development, & documentation of equipment, tooling, fixtures, and/or processes required for new products, product changes and enhancements.
  • Write & perform IQ/OQ/PQ protocols where applicable.
  • Support prototype and pilot production and facilities engineering and planning when appropriate.
  • Work with QA & supply chain to locate, qualify and oversee outside vendors and consultants as required.
  • Develop and implement alternate materials, delivery, and assembly techniques that will provide cost savings.
  • Participate in cost studies, equipment recommendation, and justifications.
  • Personal Protective Equipment:  Familiar with, and comfortable using typical PPE as appropriate, such as chemical/heat resistant gloves, UV eye protection, safety glasses, splash aprons, cleanroom gowning wear (smocks, head covers, beard covers, shoe covers).
  • Job duties are typically performed in an office, or cleanroom environment. Overall duties require the ability to stand or sit for lengthy periods of time in an office or lab. Required duties include utilizing standard lab equipment such as a microscope, hand tools, and soldering iron, and reading and writing.  
  • Other duties as assigned.


Qualifications
Qualifications
  • A Bachelor’s Degree and a minimum of six years of related experience is required.
  • A minimum of 3 years in the medical device industry is required.
  • Ability to work independently on complex engineering projects is required.
  • Must have strong oral and written communication skills.
  • Familiarity with DOE, and statistical techniques as it relates to data analysis and process control is preferred.
  • Familiarity with processes, materials, and regulations associated with implant manufacturing is preferred.
  • Familiarity with various metrology methods used in medical device manufacturing & inspection; e.g. calipers, micrometers, optical measurement systems, etc. is required.
  • Proficient with a standard MS Office software suite operating on a PC is required.
  • Proficient with the current Good Manufacturing Practice cGMP/QSR requirement, and ISO 13485.
  • Proficiency in writing and executing protocols for IQ/OQ/PQ.
  • Proficient using SolidWorks CAD software is an asset.
  • Desired proficiency with multiple typical small medical part manufacturing processes:
    • Soldering & brazing
    • Coatings such as hydrophillics, parylene, PTFE, etc.
    • Cleaning
    • Crimping
    • Packaging & pouch sealing
    • Nitinol processing (cutting, heat setting, electropolishing, etc)
  • Experience with “Arena” document control system a plus
  • This position is located in the Los Gatos, CA area and will require up to 10% travel (domestic and/or internationally).
 

Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

 

Johnson & Johnson Companies are equal opportunity employers.



Primary Location
United States-California-San Jose
Organization
DePuySynthes Products Inc (6149)
Job Function
Process Engineering
Requisition ID
6931170119

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