Job Description: SummarySupport to the engineering staff to build and test proto and pilot instruments, to include assisting the project engineer in creating the manufacturing process. May include test fixtures assembly and bring up.
Responsible for supporting the project engineer in development of the instrument and manufacturing processa. For Operations the role is to assist the engineers in the creation of a manufacturing process, to include: Proto assembly, Pilot build training, Assembly instruction creation and material management/expediting, and others tasks to assit the engineer. Further responsible for the management and cleanliness of the engineering lab. For test support, the role is to create, assemble, maintain, and support test fixtures and test solutions.
Technician will work on problems of diverse technical scope where self-initiation is required. Works with
R&D engineers, Test Engineers, Test Technicians, contract manufacturers, and Program Managers to ensure test fixtures, assembly methods, and processes are developed as suited to the application and installed. Individual is responsible for procuring material, creating documentation, and assembling various electro-mechanical assemblies and systems. Performs other tasks assigned by management as required.
DUTIES AND RESPONSIBILITIES
Support the development and maintenance activities for: assembly aids, assembly methods, Printed Circuit Board fixtures and electromechanical test fixtures. Through technical understanding translates engineer designs into robust elegant hardware solutions
Design and manufacture hardware and cabinet structures
Wire and cable test fixtures
Bring up and debug test fixtures
Using standard applications author fixture documentation(wire harness schematics, Bill of
Materials, CAD for mechanical solutions
Follow quality systems and procedures in support of medical products in a regulated environment
Coordinate resolution of technical issues.
Advance test concepts within the organization and company
Work in a cross functional environment with manufacturing engineering, quality, R&D, purchasing and logistics to ensure our products meet customer requirements through application of test fixtures and test processes:
Work with suppliers to develop, purchase and bring up mechanical fixtures and tools
Support automation programs in-line with the test methodology
Engages early in the design process to assist with design prototypes and feasibility studies
Supplies support to contract manufacturing partners for outsourced test fixtures & products
Builds and verifies test solutions
Manage the engineering lab to ensure cleanliness, tool availability, spare part availability,
Ensure technical issues are assessed and resolved. Ensures there is a closed loop corrective action in place to ensure closure.
General expectations are to abide by company policies and procedures. Ensures effective use of material, standards, processes, equipment, and personnel in producing quality solutions at a reasonable cost using industry standard tools and application. Support the training and coaching of the contract manufacturers and technician teams. Keeps abreast of the basic requirements for FDA and ISO compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management. Follows
BDIS Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Participates in EH&S programs. Notifies management of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment. Performs other related duties and assignments as required.
KNOWLEDGE AND SKILLS
High level of mechanical ability
Can interpret electronic schematics
Effective planning and organizational skills
Strong computer skills
Effective interpersonal skills
Effective analytical, technical, and problem-solving skills
Effective English written and oral communication skills
Demonstrated ability to utilize Microsoft Excel & Word.
EDUCATION AND EXPERIENCE
Requires a two year degree as an Engineering Technician, or equivalent associates degree in technology
Experience in assembly of electro-mechanical devices and systems
Demonstrated ability to work independently
5-7 years of experience in a technology role
Knowledgeable of test and debug into complex systems
Can use common tools such as DVMs, Signal generators, Oscilloscopes
Experience in creating product documentation
Willing to travel moderately (2-3 times per year for 1-2 weeks)
cGMP familiarity with 21 CFR part 820, medical device manufacturing experience desired
Desire IPC 610 certification
Primary Work LocationUSA CA - San Jose
Work Shift1st Shift 830am-5pm (United States of America)
BD (Becton, Dickinson And Company)