Manufacturing Engineer

Intuitive•Sunnyvale, CA

10d

About The Position

The successful candidate will contribute to the successful support and advancement of high-volume manufacturing for stapler products. This role involves keeping the line running by troubleshooting equipment and fixture errors, test failures, and general assembly problems. The candidate will also lead efforts to improve quality, reliability, manufacturability, capacity, and/or cost, and make careful, sound decisions in a high-energy, team-oriented manufacturing environment.

Requirements

Experience in mid/high volume manufacturing of complex mechanisms including SPC knowledge.
High mechanical aptitude.
Experience in DFM assessment and BOM development.
Use of Agile or similar lifecycle management system tool.
Strong oral and written communication skills.
Experienced in ISO 13485 medical device manufacturing environment.
BS degree in Mechanical, Manufacturing, or Mechatronic Engineering discipline or equivalent work experience.

Nice To Haves

CAD experience a plus (SolidWorks)
Sterilized medical device experience a plus.

Responsibilities

Daily support for the Manufacturing Line.
Provide technical support and failure analysis for discrepant production components and assemblies.
Manage the assembly’s material configuration (BOM) and manufacturing process (Traveler).
Develop, maintain, and improve manufacturing processes using pFMEA as a guide.
Design, build, document and/or specify manufacturing assembly fixtures.
Establish and perform IQ/OQ/PQ/PPQ as necessary.
Support Design Verification and Validation (V&V) activities.
Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.
Assist supplier quality engineers with material procurement issues.
Support quality system compliance including, discrepant material dispositions, ECO implementation, and nonconforming evaluations.