Job Title

Product industrialization Engineer

Job Description

Position: Product industrialization Engineer

Key Responsibilities:

• PI Engineer for the Clinical Applications and Devices Consumables portfolio

• Executing to the Supply Chain responsibility priorities: • Prioritize and address any Safety related issues

• Improve the teams execution of Regulation and QMSR Compliance thru 100% training compliance, continuous monitoring of product quality. • Focus on Product Quality - Actively identify, investigate, and address quality issues with impact the customer via DOA, DEFOA, for product on time shipments

• Practice a continuous improvement mind set with a focus on LEAN business processes, manufacturing processes, and communications. Monitor yield and supplier quality performance to reduce the cost of non-quality of materials and/or operational execution

• Work with supplier, commodity manager, and procurement engineering to improve OEM or contract manufacture quality with improvement of product quality, SCAR-supplier corrective action records and documented actions

• Proactively engage with the assigned business category operational excellence priorities, business objectives, and NPI initiatives

• Collaborate and participate in identifying and implementing cost savings programs such as BOM Cost Savings and productivity of business processes

• Identify your individual opportunities to strengthen your own skill set to further engage and constructively challenge the performance of the team.

• Works as an integrator together with experts and stakeholders from in- and outside the Supply Chain management function, including Quality & Regulatory and IT.

• Understand systems, master data, and data architecture to pull data from numerous tables and from multiple sources to be merged and analyzed. 

• Facilitate data mapping and data verification sessions.

• Collaborate with business stakeholders and based on findings submit recommendations(s) for business processes.

• Provide input to documented business and data requirements (URS and FRS) and create/update business processes / QMS documents within the Supply Chain. 

• Support UAT Testing.

• Create/Update/Support Training

• Assist and lead continuous improvement through Lean methodologies

• Establishing appropriate methods, tools, equipment, etc. required to produce products in keeping with the Quality Management System and related stands (ISO 13485:2003 and GMP).

• Perform other duties as required to support the needs of the business

Requirements:     

• BS Engineering discipline or technical field (MBA with concentration in Operations – preferred)

• 5+ years of experience in Supply Chain and Operations

• Experience with ERP applications and data repositories

• Familiarity with Process, Master Data, IT infrastructure, QMS and Product Labelling

• General understanding of product development process and design control.

• Ability to build highly effective teams

• Ability to work in a cross functional environment at remote locations

• Strong interpersonal and communication skills required

• Methodical, effective troubleshooting/problem solving skills required

• Experience IQ, OQ, PQ Validation Strategies preferred

• Experience with FDA-regulated medical device manufacturing in a Lean production environment preferred

• Experience with Microsoft Office tools required

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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