Manufacturing Engineer

A

Location: Shelburne

Type:

Education:

Experience:

We are looking for an innovative Manufacturing Engineer to join our R&D team in the development and production of embedded systems for use in consumer electronics, medical devices and simulations. As a member of a dynamic team of engineers, you will have responsibilities to support Manufacturing by leveraging your skills and experience to institute controlled processes and modernize the manufacture of delicate sensors used in medical devices; and by designing and developing manufacturing tools/fixtures and products. The selected candidate will have responsibility and ownership for continuous improvement efforts for existing processes; play a crucial role in implementing lean principles in order to realize efficiencies and increase year over year throughput; orchestrate the introduction of new or customized products; and help drive designs from concept development through engineering, prototyping, and testing.

What Will You Be Doing:

  • Compile, review, and measure process performance to gauge, define, and recommend changes to reach product quality and efficiency goals.
  • Modernize and standardize the manufacture of electro-mechanical medical devices via the development and adoption of controlled processes.
  • Provide outstanding customer support both internally and externally to resolve issues and deliver effective, novel, and timely solutions.
  • Effectively apply proprietary and industry standard manufacturing processes.
  • Oversees generation of manufacturing assembly and test documentation as required for New Product Introduction (NPI), including development and deployment of standard work instructions.
  • Provide feedback in DFx reviews including design for cost, design for manufacturability, and design for assembly, at key points through the product development to ensure commercial viability.
  • Own the support, maintenance, update, and commissioning of manufacturing equipment.
  • Own the development and maintenance of manufacturing processes.
  • Provide input to the design transfer or new products to Manufacturing, including ownership of assembly procedures and quality plans once released by Engineering.
  • Manages all manufacturing/process related Engineering Work Request (EWR) for NDI-Shelburne, developing cost, resource, and lead-time estimates; create, implement and track progress of approved efforts using project plans; and serves as prime technical contact.
  • Execute mechanical design of plastic and metal components and assemblies, including the production of detail drawings and specifications, review and selection of material/process, tolerance studies and First Article Inspections, prototyping of component concepts and assemblies, and execution of verification tests.
  • Work closely with functional areas across R&D, Purchasing, Manufacturing, and Sales & Marketing
  • Interface with vendors and outside resources, including the ability to travel to resolve issues with suppliers

Quality Requirements:

NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices and employees of NDI.  Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold.  Employees of NDI are instrumental to our compliance efforts, and are required to understand and comply with the QMS.

 What Will You Bring To The Role:

  • Bachelor’s degree in Industrial, Mechanical, or Electro-Mechanical Engineering
  • 3+ years’ experience in manufacturing of precision instruments/devices
  • Experience in an ISO 9001 manufacturing environment
  • Experience with LEAN Manufacturing Methodologies and their implementation
  • Demonstrated design for manufacturability skills
  • Able to create moderately complex but robust surface, solid, and assembly models as well as detail design drawings
  • Experience with electronic assemblies, harnesses, and prototype components
  • Thorough understanding and practical application of Geometric Dimensioning and Tolerancing (ANSI 14.5Y 2009 & 1994)
  • Demonstrated use of engineering thought in the planning, execution, and documentation of designs
  • Strong communication skills, including written and spoken English

Desired Characteristics/Additional Assets:

  • Experience with NPI, including small prototype runs
  • Flexible tool set with ability and desire to support various business needs including rapid prototype design and development, manufacturing process/tool improvement, and meticulously-executed medical product release
  • Proficient in the use of PTC Creo
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, & Outlook)
  • Experience with C/C++
  • Experience with Epicor ERP
  • Attention to detail
  • Experienced with the design of precision metal and plastic components
  • Experience in the development and manufacture of small magnetic sensors
  • Experience with mechanical packaging and manufacture of electronic components
  • Highly-motivated, results-orientated individual, who can work well independently and in teams
  • Experience with Polarion (ARM) and Aras (PLM)
  • Ability to self-manage multiple projects and prioritize in a dynamitic environment
  • Proactive communication of project progress, status, and blockers to stakeholders, ensuring appropriate review and support.

Qualifications

Education

Preferred

Bachelors or better in Manufacturing Engineering Technology or related field.

Bachelors or better in Mechanical Engineering or related field.

Experience

Required

3 years: experience in manufacturing of precision instruments/devices

 

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