Product Engineer

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Madison, WI
5 - 7 years experience
Salary depends on experience
Posted on 09/22/17


The Product Engineer is responsible for design transfer of new or updated products from Development to Production (NPI), manufacturing engineering support of products currently in production, and lifecycle support of systems in field to ensure Accuray provides products that meet customer needs in accordance with Accuray quality procedures and regulatory requirements.  In addition, expertise in a specific component, technology, or system is developed/required of all product engineers to position the production engineering team as a technical resource to the business.


     New Product Integration (NPI):

  • Serve as a Product Development Team (PDT) wedge lead to ensure manufacturing project deliverables and business goals are met for new and updated products.

  • Support PDTs directly with design transfer activities to manufacturing.

  • Develop product assembly and test protocols based on design requirements.

  • Develop and validate new tooling and test devices.

  • Develop system level BOMs and system configurations.

  • Develop Lean facility requirements to accommodate production including; workflow, shelving, other storage, and employee workstations.

  • Plan, execute, and document process validation for new or updated processes.

  • Develop product packaging and shipping work instructions.

     Production Support:

  • Create and manage changes to current products (ECOs) through implementation into production.

  • Conduct review and disposition of Non-Conforming Materials Reports (NCMRs).

  • Provide engineering support for production fixtures and tooling.

  • Maintain manufacturing work instructions and test processes for production personnel.

  • Monitor special facility controls that may be required, such as ESD, safety, cleanliness, etc.

  • Define and evaluate results of first article and ongoing inspections.

     Product/Sustaining Engineering:

  • Identify and implement hardware and process solutions to improve cost, quality and ease of manufacturing/servicing of the product.

  • Identify/implement solutions for component obsolescence issues within the form/fit/function of the existing design.

  • Investigate field failures and Out-of-Box (OOB) failures to identify root cause, and implement solutions within the form/fit/function of the existing design.

  • Provide in-depth regulatory affairs support as required, e.g., supporting complaints investigation.

     Areas of Specialization:

  • New product introductions, design transfers, project leadership within production.

  • Engineering support for computer hardware assemblies, networking components, software and operating systems.

  • Development of product structure models (Product Builder).


  • Bachelor of Science degree in an engineering field.

  • Five plus years of manufacturing engineering experience in device assembly & test and/or engineering project leadership.

  • Proven problem solving and improvement skills: DMAIC, Six Sigma, Lean.

  • Skills and aptitude to lead projects and coordinate work of others.

  • Good written and verbal communication skills, with all levels of employees, suppliers, and customers.

  • Experience in ESD and cleanliness special control processes.

  • Experience in medical device manufacturing.

  • Experience with safety and health (OSHA), FDA and ISO 9001 quality system requirements.

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