Individual we are looking for is a highly motivated individual eager to learn PCBA and system engineering projects assigned to him/her. We are currently looking for an individual who wants to learn and practice manufacturing methodology of Medical products, draft and write Medical documentation from A to Z, perform PCBA and system level DOE’s, analyze critical to quality risk factors in PCBA and system builds.
1. INDUSTRY GENERIC DESCRIPTION:
Responsible for providing the technical manufacturing engineering support to both internal (shop floor) and external customers that assures the absolute highest quality and efficiencies to all aspects of the manufacturing process
2. ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Design and implement manufacturing work cells incorporating lean, 5s & continuous quality and efficiency improvement initiatives/methodology
· Establish operating equipment specifications, improve manufacturing techniques, and introduce new process equipment to production.
· Work closely with customers on mechanical assemblies to provide input which enhances quality, assembly efficiencies, and cost.
· Develop manufacturing documents such as assembly instructions/ MPIs, process specifications and Medical products qualification procedures( PFMEA,VMP,IQOQPQ,..), and procedures for the mechanical system integration process for both new and sustaining products
· Adhere to ISO/AS9100/ISO13485 standards and other business standards
· Provide training and guidance to production personnel
· Identify and implement quality improvement initiatives.
· Do time studies for use in quote alignment, line balancing, efficiency improvements and capacity analysis
· Identify cost saving proposals and implement them
· Create and maintain complex process routing on all products
· Work on Engineering assignments and special projects which may be complex in nature where considerable judgment and initiatives are required in resolving problems and making recommendations
3. QUALIFICATION REQUIREMENTS:
A. REQUIRED SKILLS
· Verbal & written communication, organization, problem solving and interpersonal skills are essential
· Proficiency with Microsoft Office (Word, Excel, PowerPoint) and Visio software
· Ability to use specialized equipment, read intricate instructions/drawings, maintain written records, work from established drawings, and related activities in contract manufacturing
· Work on unique assignments which are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations
· Working knowledge of MCAD is a plus
· Working knowledge of Oracle is a plus
· Knowledge of Medical documentation hierarchy and ISO13485 is a plus
· Working knowledge of Minitab and SPC methods to analyze Medical products.
B. REQUIRED EXPERIENCE
· Minimum of 1 year of relevant experience working with mechanical assemblies in a system integration environment or
· Experience with manufacturing of electromechanical products in an EMS environment preferred
· Knowledge of printed circuit board assembly is a plus
C. REQUIRED EDUCATION LEVEL
· Bachelor’s degree in Industrial, Mechanical, or Manufacturing Engineering or related technical discipline. M.S. preferred.
· Associates degree or at least two years completed towards BS degree in Engineering or other technical discipline plus a minimum of 3 years of relevant experience working with mechanical assemblies in a system integration environment
Office: 408.235.7500 x 523 | Direct: 408.954.3827 | Mobile: 408.747.9886
1873 Barber Lane | Milpitas, CA 95035 | USA