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8 Jan 2021

Full-Time Manager, Manufacturing Engineering Support

Accuray Inc. – Posted by Accuray Inc. Madison, Wisconsin, United States

Job Description

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Job Description

Summary:

The Manager, Manufacturing Engineering, is accountable / responsible, with commensurable authority, for the transfer of new or updated Accuray products to production, development of tools and procedures to support production assembly & test, and leadership for manufacturing engineering support of current products, components & service part inventory to ensure Accuray can provide products that meet customer needs, and in accordance with Accuray quality procedures and regulatory requirements.

Essential Duties and Responsibilities:

  • Identify, hire, train, influence and direct staff resources required to deliver new product introductions, product change implementation, tool & test development, on-going maintenance of parts and BOMs, process improvement, and service part management that meets Accuray business goals and objectives.
  • Develop, maintain, and execute business processes related to the Manufacturing Engineering function (e.g., developing work processes and instructions, tool and test development, managing obsolescence, improvement projects, design transfer, out of box failure investigations, returned & non-conforming material investigation and disposition).
  • Interface with Product Development personnel to facilitate the transfer of product designs into manufacturing.
  • Occasionally operate as wedge lead for complex projects, and lead large business process improvement projects.
  • Assign and lead resources to support the continuous improvement of quality, reliability, serviceability, cost, and manufacturability of Accuray products and manage implementation of product changes through Engineering Change Orders (ECOs).
  • Work cross-functionally with Engineering and Quality to define processes and requirements for received materials and in-process product, including evaluation of results part inspections and final product inspection and test.
  • Manage resources and budgets required to define, develop, design/procure, and maintain production fixtures and tooling, and to develop the facility to accommodate production, storage, workstations, ESD controls, and cleanliness requirements.
  • Oversee review of materials in the Material Rejection Area (MRA) to promote
  • resolution of material issues, including the promotion of timely corrective action by the supplier(s).
  • Assign and lead resources to develop packaging so the product and Field Replacement Units (FRUs) can be transported to the customer without damage.
  • Oversee Manufacturing Engineering support for the repair center, including tooling and procedures.
  • Provide support for regulatory affairs as required to maintain production processes and facilities in accordance with FDA, OSHA and other applicable regulations.
  • Support the Quality Management System and Environmental Health and Safety Program by following procedures and mentoring others.

Qualifications:

  • Bachelor of Science or higher degree in an engineering field, such as EE, ME, IE.
  • Minimum 3 years experience leading, managing, and developing engineering or other professional employees.
  • Minimum 5 years engineering experience working in engineering activities applying problem solving skills (e.g., Six Sigma, probability and statistics) and process improvement (e.g., Lean).
  • Medical device manufacturing experience.
  • Experience with constructional data forms and electrical standards.
  • Experience with safety and health (OSHA).
  • Skills and aptitude to execute on, lead projects and coordinate work of others.
  • Good written and verbal communication skills with all levels of employees, suppliers, and customers.   
  • Experience with personal computer systems, including enterprise resource planning (e.g., SAP, Oracle), web applications, Agile, MS Office, SolidWorks, and OrCAD, MS Project, Visio, LabView, and or Minitab.
  • Experience in writing, reading and interpreting the documentation of designs and production processes.
  • Experience in product testing and calibration control processes, developing and using test equipment, troubleshooting and problem solving.
  • Experience with high-level integration and test.
  • Experience in ESD and cleanliness special control processes.
  • As required, assist in the identification, hiring, and training of assembly personnel required to assemble, test, and distribution of the devices in accordance with the relevant assembly and test work instructions and quality system requirements.
  • Train and mentor subordinates for organization stability and individual growth.
  • Hold ECO approver authority role.
  • Act as a strong Accuray advocate globally.
  • Experience with FDA and ISO 13485 quality system requirements.

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the US on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.

How to Apply

Please apply via the provided Workday link.

Job Types: Full-Time.

Job expires in 37 days.

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