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,
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.
- 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
- Participate with
QA, R&D, & Supply Chain to address component & process
specifications & other materials supply issues
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.
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
- 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
- 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
- Proficient using SolidWorks CAD software is an
- Desired proficiency with multiple typical small
medical part manufacturing processes:
- Soldering & brazing
- Coatings such as hydrophillics, parylene, PTFE,
- Packaging & pouch sealing
- Nitinol processing (cutting, heat setting,
- 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
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.
United States-California-San JoseOrganization
DePuySynthes Products Inc (6149)Job Function
Process EngineeringRequisition ID
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