Summary Responsible for creating visionary/technical direction of test development projects, project management; and coordination of junior engineers and technicians. Further responsible for the development, and support, of manual and automated test fixtures and test processes. These tests are used to support production, feasibility studies, reliability testing, and failure analysis. Engineer will work on problems of diverse technical scope. Works with R&D engineers, test technicians, contract manufacturers, and program managers to ensure test fixtures and processes are developed as suited to the application. Individual is responsible for leading teams to develop test solutions that are automated and scaled to the needs of a product or project. Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Acts as an advisor to peers to meet schedules and resolve technical problems. Performs other tasks assigned by management as required. Job Description
1. Support and manage test development activities with responsibility for results in terms of costs and methods. Performs the activities of test development and test support.
- Through technical understanding translates product designs into testable assemblies and systems
- Apply advanced automation techniques in support of developing easy to use, robust test fixtures that are scalable and modular
- Stay abreast of industry technology through active training and application.
- Follow quality systems and procedures in support of medical products in regulated environment
- Coordinate resolution of technical issues.
- Advance test concepts within the organization and company
2. Works 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:
- Works with suppliers to develop mechanical fixtures and tools
- Creates automation programs in-line with the test methodology
- Engages early in the design process to assist with design concepts, design reviews, and feasibility studies
- Supplies support to contract manufacturing partners for outsourced test fixtures
- Builds and verifies test solutions
- Ensure technical issues are assessed and resolved. Ensures there is a closed loop corrective action in place to ensure closure.
- Implementation, verify, and validate new test tools.
3. Creates test solution budgets to ensure adequate resources are provided and utilized in the most efficient and cost effective manner to meet operational objectives.
4. Abides by company policies and procedures.
5. Ensures effective use of material, standards, processes, equipment, and personnel in producing quality test solutions at a reasonable cost using industry standard tools and application.
6. Support the training and coaching of the engineering and technician teams.
7. Create and reviews team related SOP's to ensure adequate process control.
8. 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.
9. 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.
10. Performs other related duties and assignments as required.
Knowledge of test and test automation
MUST HAVE LABVIEW PROGRAMMING SKILLS and Preferably a Certification (COD)
Effective planning and organizational skills.
Effective interpersonal skills.
Effective English written and oral communication skills.
Effective goal setting skills.
Effective analytical, technical, and problem-solving skills.
Effective presentation and meeting facilitation skills.
Effective leadership and coaching skills.
Demonstrated ability to promote teamwork and to motivate exempt and non-exempt associates.
Demonstrated ability to utilize Microsoft Excel & Word.
EDUCATION AND EXPERIENCE
Requires a BS in an engineering discipline, or related Science discipline (CSE/EE preferred)
Experience developing fixtures/hardware/software in support of test solutions
Demonstrated ability to use software design tools such as Labview, and Test Stand.
7 -10 years of experience in test development.
Knowledge of Python preferred
Knowledgeable and hands on in Functional Test techniques
Experience in writing and reviewing test specifications and procedures
Willing to travel moderately (4-5 times per year for 1-2 weeks)
cGMP familiarity with 21 CFR part 820, medical device manufacturing experience preferred
Desire an ability to create and manipulate typical data base technologies Primary Work Location USA CA - San Jose Additional Locations Work Shift