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Staff Manufacturing Engineer

Company: Smith & Nephew
Location: Memphis
Posted on: September 24, 2022

Job Description:

Summary:

* Lead all aspects of multiple manufacturing/automation projects. Ensure manufacturing requirements, cost, quality, and timing expectations are met.
* Design and/or oversee manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
* Design and/or oversee the arrangement of machines within plant facilities to ensure most efficient and productive layout.
* Design and/or coordinate sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.
* Adapt and/or oversee machine or equipment design to factory and production conditions.
* Responsible for oversight of incorporating inspection and test requirements into the production plan.
* Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate/initiate corrective action of problems and deficiencies to ensure product quality.
* Develop and/or oversee manufacturing processes that are applicable to statistical process control and may develop those techniques.
* Provide mentorship to engineering regarding design concepts and specification requirements to best apply equipment and manufacturing techniques.
* Ensure processes and procedures follow regulations.
* Provide technical solutions and improvements to manufacturing processes and ensure cost and quality.
* Independently define goals and manage machine development and automation projects, participate in developing plans, responsibilities, and timelines. Able to drive through challenges to deliver on commitments. Communicate clearly in verbal, written, and graphical formats. Ability to multi-task and manage programs.
* In-depth understanding of Medical standards such as FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR. Understand medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation. Drive equipment, process, and software qualifications.
* Maintain knowledge of Programmable Logic Control (PLC), machine vision and automated inspection methods.
* Demonstrate a passion for driving innovation, process capability and delivering results that serve patient and business needs. Effectively listen to others by asking clarifying questions that gain an understanding of other points of view. View and communicate change as a way of life and address resistance to change appropriately.

Nice to Have:

* Advanced Degree in Science or Engineering
* Proficiency in the development of product requirements into machine User Requirement Specifications (URS) that mitigate patient risk through PFMEA traceable URS risk mitigations
* Knowledgeable in the understanding and development of software validation plan and reports
* Strong verbal and written communication and presentation skills
* Experience in legacy PLC platforms
* Experience in developing equipment for use in a cleanroom environment

Job Requirements:

* Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, or similar field.
* Minimum of 7 to 10 years' experience in Manufacturing of medical equipment that includes CNC machining.
* Experience with FDA standards and ISO 13485.
* Project Management experience managing capital projects over $1M.
* Experience with equipment installation and validation activities (URS, FDS, IQ, OQ, PQ, VRA).
* Materials experience/knowledge with manufacturing using (all or some): Titanium, Cobalt Chrome, Stainless Steels, medical-grade plastics, etc.
* Experience in applying Good Automated Manufacturing Practices to machine design.
* Experience with GD&T (Geometric dimensioning and Tolerancing)
* Demonstrated experience with process improvement projects using 6 Sigma principals.

Travel:

* Position may require up to 10% travel.

Comments:

This job description is an outline of the major recurring responsibilities of the job and is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives and special assignments.

About Us:

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living! We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential!

Care, Collaboration, & Courage:

Care means that we show empathy and understanding for each other, our customers, and patients.

Collaboration means we work together as a team, based on mutual trust and respect.

Courage is about continuous learning, innovation, and accountability.

Veterans are strongly encouraged to apply.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Keywords: Smith & Nephew, Memphis , Staff Manufacturing Engineer, Engineering , Memphis, Tennessee

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