Manufacturing Engineer in Sunnyvale, CA at DISYS

Date Posted: 6/23/2018

Job Snapshot

Job Description

ROLES AND RESPONSIBILITIES:


•        Work with team to create, maintain and improve pilot “mid-volume” manufacturing assembly line, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.


•        Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.


•        Analyze instrument manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.


•        Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).


•        Provide production support through successful and sustained project launch.


•        Support identification of and implementation of continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.


•        Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.


•        Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.


•        Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.



REQUIREMENTS:


•        BS / MS degree in Engineering discipline or equivalent work experience.


•        5-7 years’ experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.


•        Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.


•        Prior responsibility for process, equipment or product validation/verification.


•        Prior experience with process development, design of automated equipment, complex mechanism manufacturing is a plus


•        New product introduction/development desirable. Robotics knowledge a plus.


•        CAD experience (preferred Solidworks).


•        Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus


Job Requirements

ROLES AND RESPONSIBILITIES:


•        Work with team to create, maintain and improve pilot “mid-volume” manufacturing assembly line, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.


•        Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.


•        Analyze instrument manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.


•        Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).


•        Provide production support through successful and sustained project launch.


•        Support identification of and implementation of continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.


•        Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.


•        Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.


•        Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.



REQUIREMENTS:


•        BS / MS degree in Engineering discipline or equivalent work experience.


•        5-7 years’ experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.


•        Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.


•        Prior responsibility for process, equipment or product validation/verification.


•        Prior experience with process development, design of automated equipment, complex mechanism manufacturing is a plus


•        New product introduction/development desirable. Robotics knowledge a plus.


•        CAD experience (preferred Solidworks).


•        Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus


Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.