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
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
- Support other departments from time to time as
required (clinical, sales, marketing, etc)
- Other duties as assigned.
- 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
- 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,
- Must be proficient using CAD software such as
- 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.
United States-California-San JoseOrganization
DePuySynthes Products Inc (6149)Job Function
Process EngineeringRequisition ID