Packaging Process Engineer II

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

Provide Packaging Engineering support to manufacturing teams, lead and execute NPD project and lead Productivity projects initiatives.  Aid packaging development activities including some package design, implements packaging process, equipment projects, material research, and sterilization testing.  Support all Clean Rooms and Product Lines for Packaging Process’, Packaging Systems, and their documentation. Supports Packaging process sustaining efforts, lead NPD process Development, lead Productivity projects and align to the Global Packaging Technology group for direction and compliance.

This position is a P2 level

What will you be doing? 

• Provide Packaging process reliability through validation(s) testing that will deliver accurate and reliable test results and is in compliance with industry standards (ISO 11607).

• Work directly with Manufacturing Engineers, R&D Engineers, and Quality Engineers to ensure packaging testing meets aggressive timeline requirements.  Provide input on packaging engineering applications to product development teams as necessary communicate the production impact proposed changes will have on existing throughput.  Aid product development teams by executing protocols to ensuring that the robust process designs meet the intended customer requirements. (5%)

• Take ownership in all aspects of packaging process and process development testing.

• Write IQ/OQ/PQ protocols and reports for packaging testing.  Write and Perform Rework Instructions as needed to resolve production issues. 

• Write MPIs, BOMs, NCRs, Routers and release documentation into agile using ECN system. Own CAPA issues related to its product line.

• Implement and monitor proper packaging standards and procedures that will protect the integrity of the product packaging system and process.

• Understand and use basic functions of SAP: 1. inventory levels (raw materials and finished goods) and 2. Product costs to gain necessary data to set priorities, perform business case analysis, analyse potential backorders, or perform component sorts.

• Resolve problems with raw materials as needed.  Work with IQA and vendors to resolve material issues.  Update part drawings and part specifications as needed to clarify information being communicated to vendors to prevent future raw material issues.

• Train operators and other engineers on technical issues and rework instructions as needed to ensure proper documentation execution.   Provide hands on training, as necessary, on packaging techniques and manufacturing packaging sealing techniques for improved results.

• Participate and Support Employee Suggestion Program as needed to implement cost saving ideas.

• Work with counterpart process engineers in the US to support DOE and lab notebook studies as required for new product development.

• Take Ownership of Manufacturing Packaging Engineering Problems; prioritize the problems using FPQ and Scrap Data, and drive problems to resolutions using 5 phase problem solving.

• Identify Areas for Continuous Improvement and Cost Reductions within MFG Packaging Engineering.

• Apply material selection and overall “best packaging approach” during process development cycle.

• Responsible for product packaging process costs, compliance to Design Control Procedures, and ultimately adherence to all relevant packaging standards.

• Define, develop, lead and implement packaging improvement projects in our manufacturing facilities.  This will be driven by quality improvement, cost reduction or other needs that follow the corporate and business unit priorities.

• Follow all requirements written on the ArthroCare Corporation induction manual, safety manual, Quality manual, internal policies, US FDA Quality System Requirements and any other required by the Corporation.

• Respect Human Integrity of every associate related with ArthroCare Corporation.

• Comply with all requirements, duties, and obligations under our Quality Management System. This includes the proper action program Management well as corrective and preventive strict adherence and compliance to all regulations, policies and quality procedures.

• Comply with the implementation of standards and occupational health programs established by the company, through a compliance with those recommendations to perform the work safely and advise the company on improvements to prevent incidents or illnesses that could damage the integrity of workers and / or the facilities and assets of the company.

• Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their field of work, in order to avoid incidents that affect the productivity and distribution of our products that may cause economic impact for the company or a breach with our customers, suppliers, shareholders and / or other key audiences.

What will you need to be successful?  

Education: Engineering bachelor’s degree (mechanical, electrical, materials, industrial).

Licenses/ Certifications: ISO/ASTM:ISO: 13845, 11607, 14971. ASTM: F88, F1886, F1114, D4169, D4332, F1980.

Experience: Packaging Engineering minimum 5 years in Medical Devices, Pharmaceutical, or Food business.

Language: Fluent in English

Knowledge:

Competences:

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion+belonging: Committed to Welcoming, Celebrating and Thriving, learn more about employee inclusion groups on our website

Other reasons why you will love it here!

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.

• Work/Life Balance: Extra days off, birthday off, voluntary hours.

• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 

• Flexibility: Hybrid work model (for more professional roles), flexible schedules.

• Training: Training program, unlimited learning.

• Extra perks: employees association, and more…

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