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Senior Manufacturing Engineer
Senior Manufacturing EngineerNextPhase Medical Devices • Rochester, NH, United States
Senior Manufacturing Engineer

Senior Manufacturing Engineer

NextPhase Medical Devices • Rochester, NH, United States
2 days ago
Job type
  • Full-time
Job description

Job Summary : Develop processes for new products to be transferred into production. Apply Lean principles to drive process efficiency improvements and cost reductions. Support Production daily so that all operations function in a safe and efficient mode. Perform maintenance and repairs to process equipment as needed.

Duties / Responsibilities :

  • Develop detailed instructions under process development that can be translated into working assembly procedures.
  • Working from drawings, specifications, and assembly procedures, effectively train production operators.
  • Design, create, test and document measurement and assembly fixtures.
  • Analyze and plan workflow, equipment placement and space requirements for new production layouts and also improve existing manufacturing efficiencies.
  • Ensure that manufacturing equipment is operating in a safe and effective manner. Define and perform preventive maintenance and repair as needed.
  • Ensure that output of the manufacturing processes is at a level according to defined standards.
  • Monitor production scrap and analyze rejects.
  • Manage and resolve production issues as they arise day to day.
  • Identify and resolve repetitive and major production issues that are adversely affecting department performance.
  • Lead and compose a cross-functional Process Failure Mode and Effect Analysis (pFMEA).
  • Support new product introductions as assigned by partnering with New Product Development engineers and participate in project team meetings.
  • Possess statistical competencies to conduct multi-factorial Design of Experiments, design and execute Process Validations, and present results demonstrating process capability.
  • Assist New Product Development engineers in the design of basic fixtures for assembly, e.g. holding fixtures, cutters, go / no-go gauges.
  • Working with an assigned Project Engineer to the product line, identify and implement continuous improvements regarding assembly techniques and equipment, improving First Pass Yields and reducing cycle time and / or scrap.
  • Must maintain training to all current Next Phase Quality Documents, including the Quality Manual and all SOP's as assigned.
  • Provide support in completing activities as assigned to resolve safety issues throughout the plant.
  • Ability to work from home on occasion with advanced approval.

Required Skills / Abilities :

  • Ability to read and interpret product and component 2D drawings, equipment schematics (electrical, pneumatic) and have a basic understanding of GD&T.
  • Sound mechanical / electrical skills and an understanding of basic machinery principles.
  • Poses a basic understanding of statistics and has the ability to conduct statistical analysis with statistical software, Minitab preferred.
  • Microsoft Office Suite, including Word, Excel, PowerPoint, Visio.

    • Education and Experience :

  • BS in Mechanical, Manufacturing, Industrial, Electrical Engineering or a related Engineering discipline.
  • 5-7 years of production support and process development experience, preferably in the medical device field.
  • Familiarity and prior experience working under ISO 13485 : 2016, ISO 14971 : 2007 and 21CFR Section 820 (FDA QSR).

    • Physical Demands :

  • Ability to lift 40 pounds.
  • Working on computer workstation for extended periods.
  • Stand on a production line for extended periods.

    • Working Hours : Monday - Friday

    8 : 00am - 5 : 00pm

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    Senior Manufacturing Engineer • Rochester, NH, United States