Sr. Engineer, Manufacturing
Location:
San Jose , California
Posted:
April 02, 2017
Reference:
6930170127-en-us

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Sr.  Engineer, Manufacturing 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. 

 

The Sr. Engineer is responsible for defining, monitoring and improving production line assembly processes of all products for Pulsar Vascular. Must be proficient with cGMP and ISO 13485, and Quality System Regulations. Able to write and implement protocols for process testing and validations. Coordinates internal and external resources for specific testing. Improve product quality, cost, yield, assembly efficiency. In addition, manage the manufacturing operations.

  • Responsible for all assembly operations development, and interface with R&D for DFM implementations.
  • Proficient with the current Good Manufacturing Practice cGMP/QSR requirement, and ISO 13485.
  • Able to write and execute protocols for process testing and validations.
  • Proficient in process, tooling, & documentation design and development.
  • Responsible for the implementation of processes, fixtures, and equipment.
  • Works with R&D, and QA to improve manufacturing processes, designs, inspection methods and documentation.
  • Directs the manufacturing process development, validation and inspection.
  • Responsible for evaluating, monitoring and reviewing existing resources and identifying resource gaps.
  • Provide updates, and presentations to sr. management on production efficiencies and status of projects.
  • Coach, manage and develop employees within the reporting structure.
  • Support other departments from time to time as required (clinical, sales, marketing, etc)
  • Other duties as assigned.


Qualifications
Qualifications
  • A minimum of a Bachelor’s Degree  and a minimum of four (4) years of professional  experience  is required.
  • Prior experience in the medical device industry is required.
  • Prior experience in a Management role is a plus.
  • Must have strong oral and written communication skills.
  • Familiarity with DOE, and statistical techniques as it relates to data analysis and process control is a plus.
  • Familiarity with clinical use, design, and manufacturing of neurovascular implants is a plus.
  • Familiarity with processes, materials, and regulations associated with neurovascular implant manufacturing is a plus.
  • Familiarity with various metrology methods used in medical device manufacturing & inspection; e.g. calipers, micrometers, optical scopes is a plus.
  • Must be proficient with a standard business software suite operating on a PC e.g. MS Outlook, MS Word, MS Excel, PowerPoint, etc..
  • Must be proficient using CAD software such as Solidworks.
  • 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
6930170127

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