Staff Manufacturing Engineer
Company: Smith & Nephew
Posted on: September 24, 2022
* 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
* 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
* Provide mentorship to engineering regarding design concepts and
specification requirements to best apply equipment and
* 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
* 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
* 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
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
* Experience in legacy PLC platforms
* Experience in developing equipment for use in a cleanroom
* 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
* 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
* Experience in applying Good Automated Manufacturing Practices to
* Experience with GD&T (Geometric dimensioning and
* Demonstrated experience with process improvement projects using 6
* Position may require up to 10% travel.
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.
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
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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