Manufacturing Process Engineer II
Business Unit: Diagnostic Imaging
Requisition Number: 237288
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Entry level
Education Required Level: Bachelor's Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Molecular Imaging division of Siemens Medical Solutions, Inc. has an
opening for a strong Manufacturing
Process Engineer II to join our
Operations team. The ideal candidate
would be someone with great communication skills who may have experience
leading teams focusing primarily on product quality and to ensure full
compliance to all FDA requirements. This position will work across a
cross-functional organization with large and diverse teams, acting in a
technical leadership role. A passion for manufacturing that
improves quality and reduces cost is essential to be a member on our team. The focus is to drive higher performance
through process improvement.
· Develop, evaluate, improve and document manufacturing processes to improve quality and reduce cost in compliance with FDA requirements and regulations.
· Improve manufacturing efficiency by analyzing work flow, material flow and space requirement to ensure on-time product shipments.
· Perform statistical analysis using diagnostic tools and techniques.
· Author, review, support execution of new process validation (Master Validation Plan, IQ, OQ & PQ)
· Represent Manufacturing on product development teams; which defines and integrates design for manufacturing requirements into each product
· Tests and verifies the manufacturing product requirement specifications.
· Support technology transfer for respective products from R&D by driving the PFMEA process
· Create a System level troubleshooting concept from PFMEA
· Coach, teach, and develop manufacturing personnel regarding processes details to allow them to increase their capability / effectiveness.
· Provide technical support for all manufacturing and quality continuous improvement program.
· Lead cost reduction initiatives along with process improvement to further our goals for continuous improvement.
· Design test fixtures and tooling to improve manufacturing processes.
· Develop measurement programs and review data to improve labor and equipment productivity.
· Create & maintain accurate product Bills of Materials & Routings
· Implement and maintain lean manufacturing techniques such as Kanban, Kaizen & 5S.
· Review and approve applicable engineering specifications and drawings for manufacturability.
· Supporting company policies and procedures, goals and objectives, FDA regulations and good manufacturing practices.
Required Knowledge/Skills, Education and Experience
• Strong Mechanical Engineering background in a related medical field.
• Excellent writing, editing and proofing skills.
• ERP experience (SAP Preferred).
• FDA medical device regulations for devises and process. (i.e. IQ, OQ, PQ)
• Exhibits skills needed to bridge gaps between technical and non-technical stakeholders
• Demonstrates the ability to manage change in rapidly evolving situations
• Strong project management skills, including ability to coordinate cross-functional teams.
• Willingness to work as part of an integrated team or independently.
• Bachelor’s degree in Mechanical Engineering.
Education, and Experience
• Manufacturing knowledge of FDA regulated medical devices.
• 3-5 years of experience in related field and successful demonstration of Key Responsibilities.
• BS in Mechanical Engineering.