Manufacturing Engineer

Job description

Primary Function of the Position The successful candidate: Contributes to the successful support and advancement of high-volume manufacturing for stapler products. Keeps the line running; trouble-shooting equipment and fixture errors, test failures, and general assembly problems. Leads efforts that improve quality, reliability, manufacturability, capacity, and/or cost. Make careful, sound decisions when faced with pressures typical of a high-energy, team-oriented manufacturing environment. Essential Job Duties Specific responsibilities for this Manufacturing Engineer position include: 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. Required Skills and Experience 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. CAD experience a plus (SolidWorks) Sterilized medical device experience a plus. Required Education and Training BS degree in Mechanical, Manufacturing, or Mechatronic Engineering discipline or equivalent work experience.