Senior Diagnostic Consumables Engineer

Company: Cepheid
Location: Sunnyvale, CA
Posted on: June 27, 2017

Job Description:

Responsible for new product development and implementing continuous

improvements to new and existing processes. Create and develop new invasive

and noninvasive medical device products from initial design to market and

manufacturing release. Investigate and evaluate existing technology. Design

and implement new methodologies, materials, machines, and/or processes.

Conduct feasibility studies of the design to determine ability to function

as intended. Coordinate and drive new and existing consumable part and

process qualifications from inception through completion in accordance with

FDA and ISO guidelines. Maintain detailed documentation throughout all

phases of research and development through manufacturing. Coordinate

activities with outside suppliers and consultants to ensure the delivery of

supplies or services needed to meet scheduled timelines. Develop and

document business practices, processes, procedures, and work instructions.

Determine and execute the most appropriate testing to address process and

system level performance issues involving cartridge consumables. Perform

failure analysis on Cepheid custom injection molded parts. Consult with

engineers and other staff members to resolve issues related to product

fabrication, product quality improvement, product assembly and automation,

cost controls and reduction. Also, consult with engineers and other staff

members to improve the interface between consumables, manufacturing

processes, and diagnostic platform.

Education and Experience

Bachelor's degree or foreign equivalent in Mechanical Engineering or

related field and five (5) years of progressive experience as Product

Engineer, Associate Engineer, Mechanical Engineer, Manufacturing Process

Engineer, or related occupation.

Skills and Knowledge

Candidate must have prior work experience in the following:

1. Failure investigations, root cause failure analysis, process engineering.

2. Plastic injection molding process experience.

3. Solid Works.

4. ANSI/ASME, and GD&T.

5. IQ, OQ, PQ, FDA, IS09001

6. Ability to understand and comply with FDA regulations and company

operating procedures, processes and policies.

7. MS Excel for data analysis and presentation in graphic formats.

8. Design of experiments and interpretation of test results.

9. Plastics ultrasonic welding and plastic injection molding/tooling

experience.

Applicant instructions: Email resumes -- with reference to job code MZDK --

to hr.info@cepheid.com

Keywords: Cepheid, Sunnyvale , Senior Diagnostic Consumables Engineer, Manufacturing , Sunnyvale, CA, California